NCT07567742尚未招募2 期
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 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年5月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Taurine (Drug)
Control
No Intervention
Patients in the control arm will receive the standard of care for RIOM.
研究者
Jun Ma, MD
Professor/chief physician, executive deputy president
Sun Yat-sen University
研究点 (1)
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