TCM oral liquid plus herbal mouthwash for radiation‑caused mouth sores in head and neck cancer

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

This study will test whether taking a Qingying oral liquid and using a modified Da Huang‑Huang Lian Xiexin mouthwash can reduce how often, how long, and how severe radiation‑induced mouth sores are in adults receiving radiotherapy for head and neck cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (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: NCT07282483 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives patients Qingying oral liquid four times daily and a modified Da Huang‑Huang Lian Xiexin mouthwash six times daily, or matching placebos, starting when mild‑to‑moderate oral mucositis (RTOG grade 1–2) first appears during radiotherapy. Treatment continues until two weeks after completion of radiotherapy, with instructions to avoid eating, drinking, or oral hygiene for one hour after each administration to maximize mucosal contact. The study compares incidence, duration, and severity of mucositis between the combined TCM regimen and placebo and monitors adverse events. Outcomes will determine whether the combined oral liquid and mouthwash reduce progression to severe mucositis and are safe in this population.

Who should consider this trial

Good fit: Adults 18–65 years old with non‑metastatic head and neck cancer, ECOG performance status ≤2, receiving radiotherapy or concurrent chemoradiotherapy who develop mild‑to‑moderate (RTOG grade 1–2) oral mucositis are the intended participants.

Not a fit: Patients with severe (grade 3–4) mucositis at onset, prior head and neck radiotherapy, poor oral hygiene or severe periodontal disease, recent use of antibiotics/antifungals or antimicrobial mouthwash, or those receiving agents known to worsen mucositis (e.g., anti‑EGFR or immune checkpoint inhibitors) are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the combined regimen could reduce pain, ulceration, and the duration of radiation‑induced oral mucositis, helping patients maintain nutrition and complete radiotherapy on schedule.

How similar studies have performed: Some small trials and case series of topical herbal rinses have reported symptomatic improvement for radiation‑related oral mucositis, but high‑quality randomized evidence remains limited.

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

• Study coordinator: Xingchen Peng, Professor

Conditions Radiation-induced Oral Mucositis