RecruitingPhase 2NCT07282483

Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Trial


Sponsor

West China Hospital

Enrollment

118 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a Traditional Chinese Medicine oral liquid and mouthwash can reduce or prevent mouth sores (oral mucositis) — a painful and common side effect of radiation therapy — in patients with head and neck cancer. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with a non-metastatic head or neck cancer confirmed by biopsy - You are scheduled to receive radiation therapy or combined radiation and chemotherapy - Your general health and organ function are adequate - Your ECOG performance status is 2 or below (able to carry out basic daily activities) **You may NOT be eligible if...** - You have a history of multiple drug allergies - You plan to use certain drugs that can worsen mouth sores (such as anti-EGFR antibodies or immune checkpoint inhibitors) during radiation - You used antibiotics, antifungal drugs, or antimicrobial mouthwash in the past month - You have poor oral hygiene or severe gum disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash

Classical traditional Chinese medicine (TCM) formulations provided as an oral liquid and a herbal mouthwash

DRUGPlacebo oral solution and mouthwash

A placebo matched in color, odor, and taste to the Qingying oral liquid and the modified Da Huang-Huang Lian Xiexin mouthwash, but containing no active medicinal ingredients.

RADIATIONradiotherapy

All subjects underwent radical radiotherapy


Locations(1)

West China Hospital

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT07282483


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