NCT07339774

Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.

Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.

Detailed description

The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral solution with a mouthwash in reducing the duration of severe radiation-induced oral mucositis (RIOM). The study addresses two primary questions: (1) whether the combined use of the TCM oral solution and mouthwash can effectively shorten the duration of severe RIOM, and (2) whether their use is associated with adverse events in patients undergoing radiotherapy. Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time. The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.

Conditions

• Radiotherapy-induced Oral Mucositis

Interventions

Type	Name	Description
DRUG	Placebo oral liquid and mouthwash	Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients
DRUG	Zishui Daohuo oral liquid combined with Kujiu mouthwash	Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
RADIATION	Radiotherapy	One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-10-31
• Completion: 2026-12-30
• First posted: 2026-01-14
• Last updated: 2026-03-25

Locations

1 site across 1 country: China