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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Mucositis (Ulcerative) Due to Radiation; Nasopharyngeal Carcinoma (NPC)
• Intervention / Treatment: Drug: Taurine

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Ma; Phone Number: +86-20-87343469; Email: yangkb@sysucc.org.cn
• Study Contact Backup: Name: Yu-Pei Chen, MD; Phone Number: +86-020-87343581

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
      • Contact: Jun Ma; Phone Number: +862087343469; Email: majun2@mail.sysu.edu.cn
      • Principal Investigator: Jun Ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Taurine; Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
No Intervention: Control; Patients in the control arm will receive the standard of care for RIOM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Severe Radiation-Induced Oral Mucositis	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset Time of Severe Radiation-Induced Oral Mucositis	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	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	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	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	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)	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	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	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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Jun Ma, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nasopharyngeal Carcinoma; Taurine; Radiation-induced Oral Mucositis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Pathological Conditions, Signs and Symptoms; Nasopharyngeal Carcinoma; Ulcer; Stomatitis; Sulfur Compounds; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Alkanes; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Taurine
• Other Study ID Numbers: 2026-FXY-049-FLK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No