RecruitingPhase 2

Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

China118 participantsStarted 2026-03-16

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Incidence rate of severe oral mucositis (RTOG grade ≥ 3)

Timeframe: From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks

Trial details

NCT IDNCT07282483

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Xingchen Peng, Professor

+8618980606753 pxx2014@163.com

View on ClinicalTrials.gov More Radiation-induced Oral Mucositis trials