A Phase 2 interventional study of Taurine granule and Placebo granule in Radiation Induced Oral Mucositis and Radiodermatitis, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Phase 2, Interventional, and Prevention
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.
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.
Exclusion criteria:
From the first day of radiotherapy to the end of radiotherapy, the control group was treated with 24 grams of placebo before each day's radiotherapy.
Drug: Placebo granule
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.
Drug: Taurine granule
24 grams of taurine granule + 2 Gray radiation dose each time.
Also known as: Radiotherapy
24 grams of placebo granule + 2 Gray radiation dose each time.
Also known as: Radiotherapy
Incidence rate and severity of acute radiation-induced oral mucositis
The severity of acute radiation-induced oral mucositis is evaluated by RTOG (Radiation Therapy Oncology Group) classification.
Time frame: The first day, the second, third, fourth, fifth, sixth week during radiotherapy; the 7±1 day, the 14±2 day, the 21±3 day, the 28±5 day after the last day of radiotherapy (follow-up); 3 month±5 days after the last day of radiotherapy (study endpoint).
Incidence rate and severity of acute radiodermatitis
The severity of acute radiodermatitis is evaluated by RTOG (Radiation Therapy Oncology Group) classification.
Time frame: The first day, the second, third, fourth, fifth, sixth week during radiotherapy; the 7±1 day, the 14±2 day, the 21±3 day, the 28±5 day after the last day of radiotherapy (follow-up); 3 month±5 days after the last day of radiotherapy (study endpoint).
Safety physiological parameters
The safety of placebo granule and taurine granule is evaluated by clinical symptoms, adverse events (assessed by CTCAE v5.0), blood routine examination (including red blood cells, hemoglobin, blood platelet, white blood cell, basophilic granulocyte, Eosinophils, lymphocyte, mononuclear leucocyte, neutrophil, etc.), blood biochemistry examination (including alanine transaminase, glutamic-pyruvic transaminase, alkaline phosphatase, total protein, albumin, total bilirubin, direct bilirubin, blood urea nitrogen, creatinine, potassium ion, sodion, chloridion, etc.).
Time frame: Clinical symptoms and adverse events are recorded when occured. Blood routine and blood biochemistry examination are evaluated during screening, after 2/4/6 weeks of radiotherapy and 4 weeks after the last day of radiotherapy.
Immunological parameters of peripheral blood
The immunomodulatory effects of placebo granule and taurine granule is evaluated by blood immunoglobulin examination (IgA、IgG、IgE、IgM) and blood CD molecule (CD3、CD4、CD8、CD16、CD19、CD56) examination.
Time frame: The blood immunoglobulin and CD molecule examination will be conducted during screening, during the last week of radiotherapy and 4 weeks after the last day of radiotherapy.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University