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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Taurine granule
  • Placebo granule

Treatment groups

160 Participants
are divided into 2 treatment groups