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 20, 2026

Study Type

INTERVENTIONAL

Conditions

Radiation-induced Oral Mucositis

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

Inclusion Criteria6

Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
Age range: 18 to 65 years old (including 18 and 65 years old);
Eastern Cooperative Oncology Group performance status of ≤2;
Radiotherapy or concurrent chemoradiotherapy is required;
The main organ functions well;
Sign informed consent.

Exclusion Criteria6

Allergic constitution (such as those known to be allergic to two or more drugs);
Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
Poor oral hygiene and/or severe periodontal diseases;
History of head and neck radiotherapy;
Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

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