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 by CRC. After the patient take the medication, the CRC takes the patient to the treatment room for radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
24 grams of taurine granule + 2 Gray radiation dose each time.
24 grams of placebo granule + 2 Gray radiation dose each time.
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence 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. The subjective feeling of radiation-induced oral mucositis is evaluated via the weekly oral mucositis questionnaire during radiotherapy.
Time frame: Day 0 (before the first radiotherapy),7,14,21,28,35,42 (after the last radiotherapy),49±1 (follow-up),56±2 (follow-up),70±5 (follow-up), 126±5 (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: Day 0 (before the first radiotherapy),7,14,21,28,35,42 (after the last radiotherapy),49±1 (follow-up),56±2 (follow-up),70±5 (follow-up), 126±5 (study endpoint).
Number of participants with 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, c reactive protein, procalcitonin, 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, calcium ion, magnesium ion, etc.), etc.
Time frame: Clinical symptoms and adverse events are recorded when occured. Blood routine and blood biochemistry examination are evaluated during screening and on day 14, 28, 42 and 70±5d.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.