Taurine to help prevent and treat mouth ulcers from radiation in NPC

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 is a Phase 2 interventional trial examining taurine as a preventive and therapeutic approach for radiation-induced oral mucositis in patients with non-metastatic nasopharyngeal carcinoma scheduled for radical IMRT. Eligible participants are adults 18 to 70 with newly diagnosed, non-keratinizing NPC, good performance status, and adequate organ function who have not yet received cancer treatment. Participants receive taurine as the intervention; the study monitors incidence and severity of oral mucositis during radiotherapy and possibly beyond. The trial is led by Sun Yat-sen University at the Sun Yat-sen University Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jun Ma — Sun Yat-sen University
• Study coordinator: Jun Ma
• Email: yangkb@sysucc.org.cn
• Phone: +86-20-87343469

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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.