Traditional Chinese oral solution and mouthwash to shorten severe radiation-induced mouth sores in head and neck cancer.

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

This trial will try a combined traditional Chinese oral solution and mouthwash to shorten and ease severe radiation-induced mouth sores in adults receiving radiotherapy for head and neck cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07339774 on ClinicalTrials.gov

What this trial studies

This randomized phase 2 trial enrolls adults with non-metastatic head and neck cancer who develop severe radiation-induced oral mucositis (RTOG grade ≥3) during radiotherapy. Participants start treatment the first day severe mucositis appears and receive Zishui Daohuo oral solution three times daily plus Kuju mouthwash six times daily, or matched placebos. Treatment continues until two weeks after radiotherapy, and patients are asked to avoid eating, drinking, or oral hygiene for one hour after each use to maximize mucosal contact. Primary outcomes include duration of severe mucositis and safety/adverse events compared between the TCM combination and placebo groups.

Who should consider this trial

Good fit: Adults aged 18–65 with non-metastatic head and neck cancer undergoing radiotherapy (or concurrent chemoradiotherapy) who develop RTOG grade ≥3 oral mucositis, have ECOG ≤2, and adequate organ function.

Not a fit: Patients with prior head and neck radiotherapy, active severe periodontal disease, recent use of antibiotics/antifungals or antimicrobial mouthwash, planned therapy with EGFR inhibitors or immune checkpoint inhibitors, multiple drug allergies, or other serious comorbidities may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the regimen could shorten time with severe mouth sores, reduce pain, and help patients complete radiotherapy with better oral comfort.

How similar studies have performed: Some small trials of topical or herbal preparations have suggested benefit for radiation mucositis, but high-quality evidence for this specific TCM combination is limited and further testing is needed.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Allergic constitution (such as those known to be allergic to two or more drugs);
2. 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;
3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
4. Poor oral hygiene and/or severe periodontal diseases;
5. History of head and neck radiotherapy;
6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xingchen Peng, Professor — West China Hospital
• Study coordinator: Xingchen Peng Professor

Conditions Radiotherapy-induced Oral Mucositis