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

RECRUITINGPhase 2Sponsored by West China Hospital
Actively Recruiting
PhasePhase 2
SponsorWest China Hospital
Started2026-03-30
Est. completion2026-10-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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).

Conditions2

CancerRadiotherapy-induced Oral Mucositis

Interventions2

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