NCT07567742Not yet recruitingPhase 2
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
Sun Yat-sen University1 site in 1 country130 target enrollmentStarted: May 6, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 1
Study Overview
Brief Summary
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-70 years.
- •Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
- •Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
- •Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
- •No prior history of anti-cancer treatment.
- •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.
- •For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.
- •Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.
Exclusion Criteria
- •Known intolerance or hypersensitivity to taurine or its excipients.
- •Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- •Prior history of malignant tumor.
- •Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
- •History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
- •Unwilling to stop smoking, drinking alcohol, or chewing betel nut.
- •Presence of severe active comorbidities.
- •Severe dysfunction of heart, brain, lung, or other vital organs.
- •Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.
- •Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.
- •Any other condition deemed inappropriate by the investigator.
Arms & Interventions
Taurine
Experimental
Oral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM.
Intervention: Taurine (Drug)
Control
No Intervention
Patients in the control arm will receive the standard of care for RIOM.
Investigators
Jun Ma, MD
Professor/chief physician, executive deputy president
Sun Yat-sen University
Study Sites (1)
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