Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

NCT05341206 | Unknown Phase 2

• 1 other identifier: 202101017A3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.

Conditions

Head and Neck Neoplasms; Chemoradiotherapy; Stomatitis and Ulceration

Keywords

Medicine, Chinese Traditional; Head and Neck Neoplasms; Chemoradiotherapy; Stomatitis and Ulceration

Outcome Measures

Primary Outcomes (1)

• Change of CTCAE 4.0

  CTCAE is used to describe the severity of oral mucositis for patients receiving cancer therapy.

  change from baseline and every week for 8 weeks.

Secondary Outcomes (8)

• Change of EORTC QLQ-C30

  change from baseline at 4 weeks and 8 weeks post treatment.

• Change of EORTC QLQ-H&N35

  change from baseline at 4 weeks and 8 weeks post treatment.

• Change of VAS of pain of oral mucositis

  change from baseline and everyday for 8 weeks.

• Change of body weight

  change from baseline and every week for 8 weeks.

• Change of opioid use

  change from baseline and every week for 8 weeks.

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

Drug: Herbal gargle

Control group

SHAM COMPARATOR

The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

Other: Normal saline

Interventions

Herbal gargle DRUG

The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

Treatment group

Normal saline OTHER

The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to join the trial project and sign the informed consent form.
• Age more than 20 years-old.
• Pathology proved to be head and neck cancers.
• Head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy.
• Expected life expectancy more than 3 months.
• Subjects with clear consciousness and can be assessed cooperatively.
• Subjects are suitable to use Herbal gargle evaluated by Traditional Chinese medicine physicians.

You may not qualify if:

• Subjects can not sing the informed consent form.
• Systemic infection.
• Heart, liver and kidney insufficiency
• Allergy history of Traditional Chinese medicine
• Unclear conscious to use Herbal gargle.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, Keelung, Taiwan, 20401, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis; Ulcer

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yi-Hsine Shiao, Doctor

CONTACT

24313131; vincentking44@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The color of Herbal gargle is yellowish while normal saline is transparent. Therefore, the study belongs to open label trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The treatment group receive Herbal gargle and control group receive normal saline.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: April 15, 2022
• Primary Completion: May 15, 2025
• Study Completion: December 31, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

TW (1)