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.
調査の概要
研究の種類
介入
入学 (推定)
130
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jun Ma
- 電話番号：+86-20-87343469
- メール：yangkb@sysucc.org.cn
研究連絡先のバックアップ
- 名前：Yu-Pei Chen, MD
- 電話番号：+86-020-87343581
研究場所
-
-
Guangdong
-
Guangzhou、Guangdong、中国
- Sun Yat-sen University Cancer Center
-
コンタクト：
- Jun Ma
- 電話番号：+862087343469
- メール：majun2@mail.sysu.edu.cn
-
主任研究者：
- Jun Ma
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
|
|
介入なし：Control
Patients in the control arm will receive the standard of care for RIOM.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Severe Radiation-Induced Oral Mucositis
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Onset Time of Severe Radiation-Induced Oral Mucositis
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jun Ma、Sun Yat-sen University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月6日
一次修了 (推定)
2027年3月30日
研究の完了 (推定)
2029年3月30日
試験登録日
最初に提出
2026年4月16日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月5日
QC基準を満たした最後の更新が送信されました
2026年4月30日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-FXY-049-FLK
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。