NCT07029178

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

A Randomized Controlled Trial on Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Implementation of double-blind: Doctors, patients and clinical research coordinator (CRC) are blind. The medicine will be encoded before the beginning of the trial, and will be administered before each radiotherapy session. After the patient take the medication, the CRC takes the patient to the treatment room for radiotherapy.

Conditions

• Radiation Induced Oral Mucositis
• Radiodermatitis

Interventions

Type	Name	Description
DRUG	Taurine granule	24 grams of taurine granule + 2 Gray radiation dose each time.
DRUG	Placebo granule	24 grams of placebo granule + 2 Gray radiation dose each time.

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-11-01
• Completion: 2027-12-31
• First posted: 2025-06-19
• Last updated: 2026-03-18

Locations

1 site across 1 country: China