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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Xingchen Peng, Professor
• Email: pxx2014@163.com
• Phone: +8618980606753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.