RecruitingPhase 2

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

China128 participantsStarted 2026-03-30

Plain-language 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.

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

The duration of severe oral mucositis (RTOG grade≥3)

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

Trial details

NCT IDNCT07339774

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Xingchen Peng Professor

+8618980606753 pxx2014@163.com

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