Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma

Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial

This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.

Inclusion Criteria:

1. Age 18-70 years.
2. Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
3. Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
4. Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
5. No prior history of anti-cancer treatment.
6. ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin > 90 g/L; absolute neutrophil count > 1.5×10⁹/L; platelet count > 100×10⁹/L. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL/min.
7. For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.
8. Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.

Exclusion Criteria:

1. Known intolerance or hypersensitivity to taurine or its excipients.
2. Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
3. Prior history of malignant tumor.
4. Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
5. History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
6. Unwilling to stop smoking, drinking alcohol, or chewing betel nut.
7. Presence of severe active comorbidities.
8. Severe dysfunction of heart, brain, lung, or other vital organs.
9. Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.
10. Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.
11. Any other condition deemed inappropriate by the investigator.