Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07029178

Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis

Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-03-18

160

Participants Needed

1

Research Sites

109 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a single-center, double-blind, randomized controlled study. The patients were divided into control group and experimental group, 80 cases each. From the first day of radiotherapy to the end of radiotherapy, the experimental group was treated with 24 grams of taurine granule (containing 4.8 grams of taurine) before each day's radiotherapy. The control group was treated with the same amount of placebo.

CONDITIONS

Official Title

Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients voluntarily joined the study, signed informed consent, and agree to follow the study protocol
  • Aged between 18 and 80 years, any gender
  • Require radiotherapy after surgery for oral or oropharyngeal cancer, planned for 30 sessions/60 Gy
  • Expected survival period of more than 6 months
  • No prior head or neck radiotherapy and no chemotherapy or immunotherapy within one month before the study
Not Eligible

You will not qualify if you...

  • Uncontrollable local or systemic infections of the oral cavity and head and neck
  • Active or history of autoimmune diseases requiring systemic steroids or immunosuppressive drugs
  • Bleeding within 3 months before enrollment or risk of major bleeding
  • Arterial or venous thrombosis within 6 months before screening
  • Interstitial pneumonia, active pneumonia affecting lung function, or serious respiratory diseases
  • History of significant cardiovascular diseases such as congestive heart failure, unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
  • Severe endocrine or blood system diseases, gastrointestinal obstruction, active bleeding, or gastric perforation
  • Concurrent malignant tumors in other organs
  • Intractable epilepsy or uncontrolled pleural effusion, ascites, pericardial effusion
  • History of HIV, syphilis, active hepatitis, active tuberculosis, or active viral infections within one year
  • History of allogeneic bone marrow or solid organ transplantation
  • Prior use of genetically modified cell therapy products
  • Previous use of medicines causing osteonecrosis of the jaw
  • Use of taurine-containing drugs within one month before randomization
  • Allergy to taurine
  • Need for chemotherapy or immunotherapy during radiotherapy
  • Mental illness, alcohol or drug abuse
  • Pregnant or breastfeeding women, or planning pregnancy within six months after treatment
  • Poor compliance or judged unsuitable by researchers for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

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Research Team

H

Heng Chen, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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