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NCT Number: NCT07567742

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

This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.

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Key information

Conditions

Oral Mucositis (Ulcerative) Due to Radiation Carcinoma Head and Neck Neoplasms Mouth Diseases Nasopharyngeal Carcinoma Nasopharyngeal Carcinoma (NPC) Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatitis Stomatognathic Diseases Ulcer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location contact

Jun Ma

CONTACT

[email protected]

+862087343469

Jun Ma

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Taurine

Drug

Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.

Primary outcomes

  1. Incidence of Severe Radiation-Induced Oral Mucositis

    Time frame: 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.

Secondary outcomes

  1. Onset Time of Severe Radiation-Induced Oral Mucositis

    Time frame: 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.

  2. Duration of Severe Radiation-Induced Oral Mucositis

    Time frame: 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.

  3. Recovery Rate of Severe Radiation-Induced Oral Mucositis

    Time frame: 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.

  4. Incidence of Radiation-Induced Oral Mucositis

    Time frame: 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.

  5. Incidence of Radiotherapy Interruption

    Time frame: 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.

  6. Quality of life (QoL)

    Time frame: 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.

  7. Numeric Rating Scale for Pain

    Time frame: 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.

  8. Safety as Assessed by CTCAE

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Ma

CONTACT

[email protected]

+86-20-87343469

Yu-Pei Chen, MD

CONTACT

+86-020-87343581

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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