Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

30 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Yu-Pei Chen, MD
  • Numéro de téléphone: +86-020-87343581

Lieux d'étude

  • Chine
    • Guangdong
      • Guangzhou, Guangdong, Chine
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Chercheur principal:
          • Jun Ma

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Taurine
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
Aucune intervention: Control
Patients in the control arm will receive the standard of care for RIOM.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Severe Radiation-Induced Oral Mucositis
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Onset Time of Severe Radiation-Induced Oral Mucositis
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sun Yat-sen University

Les enquêteurs

  • Chercheur principal: Jun Ma, Sun Yat-sen University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

6 mai 2026

Achèvement primaire (Estimé)

30 mars 2027

Achèvement de l'étude (Estimé)

30 mars 2029

Dates d'inscription aux études

Première soumission

16 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-FXY-049-FLK

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner