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

2026年4月30日 更新者：Jun Ma, MD、Sun Yat-sen University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

130

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Yu-Pei Chen, MD
  • 电话号码：+86-020-87343581

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国
        • Sun Yat-sen University Cancer Center
        • 接触：
        • 首席研究员：
          • Jun Ma

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Taurine
Oral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM.
药品：Taurine
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
无干预：Control
Patients in the control arm will receive the standard of care for RIOM.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Severe Radiation-Induced Oral Mucositis
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
The incidence of Grade ≥3 radiation-induced oral mucositis (RIOM) in the experimental and control groups, as assessed using the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
From the start of radiotherapy to 4 weeks after completion of radiotherapy

次要结果测量

结果测量
措施说明
大体时间
Onset Time of Severe Radiation-Induced Oral Mucositis
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
The interval from the start of radiotherapy to the first occurrence of severe radiation-induced oral mucositis (RIOM). Severe RIOM is defined as Grade ≥3 according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
From the start of radiotherapy to 4 weeks after completion of radiotherapy
Duration of Severe Radiation-Induced Oral Mucositis
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The interval from the first occurrence of severe acute radiation-induced oral mucositis (RIOM) to its resolution to Grade ≤2, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale. Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Recovery Rate of Severe Radiation-Induced Oral Mucositis
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
The proportion of patients whose severe acute radiation-induced oral mucositis (RIOM) resolves to Grade ≤2 during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale. Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiation-Induced Oral Mucositis
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
The proportion of patients who develop any-grade acute radiation-induced oral mucositis (RIOM) (Grade ≥1) during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiotherapy Interruption
大体时间：From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
The proportion of patients who experience a radiotherapy interruption of 5 or more consecutive days during the radiotherapy period due to acute radiation-induced oral mucositis (RIOM) or other related adverse events.
From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
Quality of life (QoL)
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
Quality of life related to head and neck symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Module (EORTC QLQ-H&N35), version 1.0. This questionnaire comprises 35 items, including seven multi-item scales and 11 single-item measures. All scales and items will be scored according to the official EORTC Scoring Manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater symptom burden and poorer quality of life.
From the start of radiotherapy to 4 weeks after completion of radiotherapy
Numeric Rating Scale for Pain
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
Oral mucositis-related pain was assessed in all participants using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
From the start of radiotherapy to 4 weeks after completion of radiotherapy
Safety as Assessed by CTCAE
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
Adverse events were monitored and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
From the start of radiotherapy to 4 weeks after completion of radiotherapy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sun Yat-sen University

调查人员

  • 首席研究员：Jun Ma、Sun Yat-sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月6日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2029年3月30日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-FXY-049-FLK

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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