Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis (NCT07029178) | Clinical Trial Compass
RecruitingPhase 2
Taurine's Therapeutic Effect on Acute Radiation-induced Oral Mucositis and Dermatitis
China160 participantsStarted 2025-11-24
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients voluntarily joined the study, were informed of the purpose and process of the study, signed the informed consent form, and were willing and able to abide by the study protocol.
✓. Aged 18 to 80, with no gender restrictions.
✓. Patients that require radiotherapy after surgery for oral/oropharyngeal cancer. After evaluation by the radiation oncologist, radiotherapy at 30 sessions /60Gy is planned.
✓. The expected survival period is more than 6 months.
✓. No radiotherapy for the head and neck has been performed in the past, and no other medications that affect the results of this trial have been used. No chemotherapy or immunotherapy was performed within one month before the beginning of the trial.
Exclusion criteria
✕. Uncontrollable local or systemic infections of the oral cavity and head and neck.
✕. Active or history of autoimmune diseases; Diseases requiring systemic steroid hormones or immunosuppressive medications.
✕. Bleeding occurred within 3 months before enrollment, including but not limited to: gastrointestinal bleeding caused by gastric fundus or esophageal varices, increased risk of bleeding caused by portal hypertension, active gastrointestinal bleeding, etc. Or there is a risk of major bleeding as assessed by the researcher.
✕. Arterial/venous thrombosis that occurred within 6 months prior to the screening, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc.
What they're measuring
1
Incidence rate and severity of acute radiation-induced oral mucositis
Timeframe: Day 1(before the first radiotherapy),8,15,22,29,36,42 (after the last radiotherapy),49±1 (follow-up),56±2 (follow-up),63±3 (follow-up),70±5 (follow-up), 126±5 (study endpoint).
Trial details
NCT IDNCT07029178
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. Interstitial pneumonia or active pneumonia with clinical significance, or other respiratory diseases that seriously affect lung function.
✕. History of cardiovascular diseases, including but not limited to: (1) Congestive heart failure (NYHA grade \> 2); (2) Unstable angina pectoris; (3) Myocardial infarction occurred in the past three months; (4) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment or intervention.
✕. Severe endocrine or hematopoietic system diseases (such as diabetes, leukemia, etc.), gastrointestinal obstruction, active bleeding, gastric perforation and other conditions.
✕. Combined with malignant tumors of other organs.