NCT03359187

Brief Summary

Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

September 26, 2016

Last Update Submit

August 4, 2020

Conditions

Radiation- Induced MucositisAdverse Effect of Radiation TherapyHead and Neck Cancer

Keywords

Radiation- induced mucositisHead and Neck CancerRadiation therapy side effect

Outcome Measures

Primary Outcomes (1)

  • Change of mucositis grading

    RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible

    Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy

Secondary Outcomes (1)

  • Patient satisfaction with the mouth wash

    The last fraction of radiation therapy, through study completion, an average of 1 year

Study Arms (3)

Normal saline with salt/Soda

ACTIVE COMPARATOR

Normal saline with salt/soda rinse 4 times a day/everyday and for each time 15 ml.

Other: Normal saline with salt/Soda

Clinacanthus nutans

EXPERIMENTAL

Clinacanthus nutans in form of mouth wash rinse 4 times a day/everyday and for each time 15 ml.

Other: Clinacanthus nutans

Boesenbergia rotunda

EXPERIMENTAL

Boesenbergia rotunda in form of mouth wash 4 times a day/everyday and for each time 15 ml.

Other: Boesenbergia rotunda

Interventions

Normal saline with salt/SodaOTHER

Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment

Normal saline with salt/Soda
Clinacanthus nutansOTHER

Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment

Clinacanthus nutans
Boesenbergia rotundaOTHER

Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment

Boesenbergia rotunda

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 15 years old or older,
  • Diagnosed with Head and Neck cancer
  • On treatment of external Radiation therapy

You may not qualify if:

  • Pregnant
  • Previously underwent external Radiation therapy
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulabhorn Hospital

Bangkok, 10210, Thailand

Location

Related Publications (1)

  • Kongwattanakul S, Petchann N, Petroch P, Thanthong S, Tungfung S, Chamchod S, Pitiporn S, Nantajit D. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial. J Complement Integr Med. 2022 Feb 28;19(3):771-780. doi: 10.1515/jcim-2021-0457. eCollection 2022 Sep 1.

    PMID: 35218685DERIVED

MeSH Terms

Conditions

Radiation InjuriesHead and Neck Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Experimental design in 3 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 26, 2016

First Posted

December 2, 2017

Study Start

February 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Locations

TH(1)