NCT07282483

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral liquid with a mouthwash in reducing the incidence, duration, and severity of mild-to-moderate radiation-induced oral mucositis (RIOM). The study addresses two main questions: (1) whether the combined TCM oral liquid and mouthwash can effectively mitigate RIOM and lower the incidence of severe RIOM, and (2) whether their use is associated with adverse events in patients receiving radiotherapy. Participants will begin treatment on the first day mild-to-moderate RIOM (RTOG grade 1-2) occurs during radiotherapy. They will take Qingying oral liquid four times daily and use a modified Da Huang-Huang Lian Xiexin mouthwash six times daily in combination, or receive a matching placebo. The treatment will continue until two weeks after radiotherapy. After each administration, patients must avoid eating, drinking, or performing oral hygiene for at least 1 hour to maximize mucosal contact time. The trial will compare the intervention and placebo groups to determine the potential benefits of the combined regimen for managing RIOM.

Conditions

• Radiation-induced Oral Mucositis

Interventions

Type	Name	Description
DRUG	Qingying 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
DRUG	Placebo 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.
RADIATION	radiotherapy	All subjects underwent radical radiotherapy

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-08-31
• Completion: 2026-10-31
• First posted: 2025-12-15
• Last updated: 2026-03-25

Locations

1 site across 1 country: China