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

NCT07567742 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-FXY-049-FLK
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Mucositis (Ulcerative) Due to Radiation; Nasopharyngeal Carcinoma (NPC)

Keywords

Radiation-induced Oral Mucositis; Nasopharyngeal Carcinoma; Taurine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Onset Time of Severe Radiation-Induced Oral Mucositis

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Duration of Severe Radiation-Induced Oral Mucositis

  From the start of radiotherapy to 4 weeks after completion of radiotherapy.

• Recovery Rate of Severe Radiation-Induced Oral Mucositis

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Incidence of Radiation-Induced Oral Mucositis

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Incidence of Radiotherapy Interruption

  From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.

Study Arms (2)

Taurine

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in the control arm will receive the standard of care for RIOM.

Interventions

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.

Taurine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Stomatitis; Ulcer; Nasopharyngeal Carcinoma

Interventions

Taurine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jun Ma

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ma

CONTACT

+86-20-87343469; yangkb@sysucc.org.cn

Yu-Pei Chen, MD

CONTACT

+86-020-87343581

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/chief physician, executive deputy president

Model Details: This is a single-center, open-label, randomized controlled Phase 2 clinical trial investigating taurine for the prophylaxis and treatment of radiation-induced oral mucositis in patients with nasopharyngeal carcinoma. Eligible participants will be randomized in a 1:1 ratio to receive taurine plus standard of care or standard of care alone.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 5, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)