NCT05648682

Brief Summary

This study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 25, 2022

Last Update Submit

December 11, 2022

Conditions

Head and Neck CancersOral Mucositis

Keywords

nurseradiotherapysalinsodium bicarbonatethyme honeyHead and Neck CancersOral Mucositis

Outcome Measures

Primary Outcomes (68)

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has oral mucositis

    Week 0

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=6 patients have oral mucositis

    First week of radiotherapy

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change= 12 patients have oral mucositis

    Second week of radiotherapy

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Third week of radiotherapy

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fourth week of radiotherapy

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fifth week of radiotherapy

  • Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Sixth week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has oral mucositis

    Week 0

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have oral mucositis

    First week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Second week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Third week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fourth week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fifth week of radiotherapy

  • Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have oral mucositis

    Sixth week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has oral mucositis

    Week 0

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have oral mucositis

    First week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Second week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Third week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fourth week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fifth week of radiotherapy

  • Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have oral mucositis

    Sixth week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has oral mucositis

    Week 0

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has oral mucositis

    First week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=8 patients have oral mucositis

    Second week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Third week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fourth week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Fifth week of radiotherapy

  • Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have oral mucositis

    Sixth week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Week 0

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=6 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    First week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Second week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Third week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have Grade 1-2 oral mucositis 8 patients have Grade 3 oral mucositis

    Fourth week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Fifth week of radiotherapy

  • Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Sixth week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Week 0

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    First week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Second week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Third week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have Grade 1-2 oral mucositis 8 patients have Grade 3 oral mucositis

    Fourth week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=10 patients have Grade 1-2 oral mucositis 2 patients have Grade 3 oral mucositis

    Fifth week of radiotherapy

  • Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have Grade 1-2 oral mucositis 1 patient has Grade 3 oral mucositis

    Sixth week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Week 0

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=4 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    First week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Second week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have Grade 1-2 oral mucositis 1 patient has Grade 3 oral mucositis

    Third week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Fourth week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=7 patients have Grade 1-2 oral mucositis 5 patients have Grade 3 oral mucositis

    Fifth week of radiotherapy

  • Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=10 patients have Grade 1-2 oral mucositis 2 patients have Grade 3 oral mucositis

    Sixth week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Week 0

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=0 patient has Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    First week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=8 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Second week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Third week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have Grade 1-2 oral mucositis 1 patient has Grade 3 oral mucositis

    Fourth week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=11 patients have Grade 1-2 oral mucositis 1 patient has Grade 3 oral mucositis

    Fifth week of radiotherapy

  • Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)

    National Cancer Institute Criteria For Adverse Events v4.03 is used to determine the severity of OM due to radiotherapy. The severity of OM is graded from 0 to 5. Grade 0 means no mucositis. Grade 1 has mucositis but no complaints or mild mucositis. There are mild ulcerations in the mouth. Grade 2 has enlarged ulcerated areas with moderately painful mucositis that does not interfere with food intake but requires a change of type. Grade 3 has severely painful mucositis and large ulcerated areas with bleeding that interfere with food intake. Grade 4 is classified as mucositis requiring immediate medical intervention and Grade 5 is death due to mucositis. Change=12 patients have Grade 1-2 oral mucositis 0 patient has Grade 3 oral mucositis

    Sixth week of radiotherapy

  • Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=83,57

    Week 0

  • Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=73,71

    Second week of radiotherapy

  • Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=65,30

    Fifth week of radiotherapy

  • Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=82,99

    Week 0

  • Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=69,67

    Second week of radiotherapy

  • Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=65,30

    Fifth week of radiotherapy

  • Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=75,31

    Week 0

  • Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=62,17

    Second week of radiotherapy

  • Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=52,56

    Fifth week of radiotherapy

  • Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=85,59

    Week 0

  • Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=73,71

    Second week of radiotherapy

  • Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire

    The 12 items included in the University of Washington Quality of Life Questionnaire question are "pain, appearance, activity, fun, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety". In its scoring, each of the answers to the 12 items is scored from 0 (worst quality of life) to 100 (the best quality of life). In each item, the worst answer is scored as "0", while the best answer is scored as "100". Change=70,42

    Fifth week of radiotherapy

Study Arms (4)

Saline

EXPERIMENTAL

The patients in the group gargling with saline were given in a 500 ml bottle at each visit for one week of use. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.

Other: Salin

Sodium Bicarbonate

EXPERIMENTAL

The sodium bicarbonate solution prepared by the researcher by mixing one teaspoon of baking soda (4.5 grams) into 500 ml of distilled water by the researcher was given to the patients in the group gargling with sodium bicarbonate for a one-week use at each interview. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.

Other: Sodium bicarbonate

Thyme Honey

EXPERIMENTAL

20 ml of honey was diluted in 100 ml distilled water bottles by the researcher to the patients in the group gargling with thyme honey. For a week's use, the patient was given five honey solutions in 100 ml bottles at one time at each visit. Patients were told that they should gargle using approximately two tablespoons of the solution given for each use.

Other: Thyme honey

Control

EXPERIMENTAL

No solution was given to the patients in the control group by the researcher.

Other: Control

Interventions

SalinOTHER

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use. SF solution was obtained from the medical company as 500 ml separately for each patient.

Saline
Sodium bicarbonateOTHER

Patients were told that they should gargle using approximately two tablespoons of the solution given for each use. The 500 ml distilled water bottle to be used for the SB solution was obtained from the medical company, separately for each patient.

Sodium Bicarbonate
Thyme honeyOTHER

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use.

Thyme Honey
ControlOTHER

The patients continued to use the antifungal solution containing the active ingredient nystatin, which was prescribed routinely in the clinical procedure, 3 times a day.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis is head and neck cancer
  • To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity
  • Not be metastatic
  • OM grade 1 (according to NCI-CTCAE v4.03)
  • Be 18 years or older
  • Volunteer to participate in the study
  • Speak Turkish

You may not qualify if:

  • Have an autoimmune disease
  • Have dental disease
  • Using dentures
  • Being allergic to thyme honey
  • Refusing to participate in the research
  • To have received radiotherapy treatment in the 6-month period before the start of the study
  • Criteria for terminating the study
  • The patient's desire to leave the study
  • Continuing the treatment in another city
  • Interruption or termination of radiotherapy treatment
  • Patient's death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep YILMAZ

Bilecik, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Fatma İlknur ÇINAR

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

  • Zeynep YILMAZ

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 13, 2022

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

TU(1)