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Not yet recruiting NCT07567742

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

Phase II Interventional Oral Mucositis (Ulcerative) Due to Radiation Nasopharyngeal Carcinoma (NPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Taurine.
Who it may be relevant to
Registry conditions: Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Incidence of Severe Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
Secondary outcome measures (8)
  • Onset Time of Severe Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
  • Duration of Severe Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.]
  • Recovery Rate of Severe Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
  • Incidence of Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
  • Incidence of Radiotherapy Interruption [Time frame: From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.]
  • Quality of life (QoL) [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
  • Numeric Rating Scale for Pain [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]
  • Safety as Assessed by CTCAE [Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07567742 · 2026-FXY-049-FLK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗