Radiation-induced intestinal injury
Conditions
Interventions
Experimental group:One EGCG capsule is taken orally daily from the day before radiotherapy to the end of radiotherapy
Control group:No oral administration of EGCG capsules
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old, gender is not limited; (2) Patients with abdominal and pelvic tumors such as cervical cancer, rectal cancer, prostate cancer, etc., who have been diagnosed by pathology and admitted to our department for preoperative neoadjuvant RT, radical RT or postoperative adjuvant RT. (3)The patient's hematopoietic function and general condition are acceptable (leukocyte > 2.5*10^9/L, platelet > 50*10^9/L, bilirubin not more than 1.5 times the upper limit of normal, liver function alanine aminotransferase and aspartate aminotransferase not more than 2.5 times of the upper limit of normal, and renal function creatinine not more than 1.5 times of the upper limit of normal) (4) No congestive heart failure, unstable angina, or unstable arrhythmia in the past 6 months (5)The patient's activity status score was 0-1 points based on the Eastern Cooperative Oncology Group (ECOG) scoring method, the functional status was >=70 points by the Karnofsky (KPS) scoring method, and the life expectancy assessment was > 3 months. (6) Able to comply with the protocol for the duration of the study.
Exclusion criteria
Exclusion criteria: (1)Pregnant or lactating women (2) History of tumor, chemotherapy, RT, except for cured skin cancer (3) Those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, whose clinical severity may be judged by the investigator to preclude the signing of the informed consent form or affect the patient's compliance with medication (4) Clinically serious (i.e., active) cardiac disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or greater congestive heart failure or severe cardiac arrhythmia requiring medical intervention, or history of myocardial infarction within the last 12 months (5)Those who need immunosuppressive therapy for organ transplantation; (6) Known major active infection, or major hematological, renal, metabolic, gastrointestinal, or endocrine disorders or other serious uncontrolled concomitant diseases as judged by the investigator; (7) The subjects' baseline blood routine and biochemical indicators did not meet the following criteria: hemoglobin =90g/L; Absolute neutrophil count (ANC) >=1.5×109/L; Platelet count >=100×109/L; ALT and AST=30g/L; (8) Allergy to any of the study drug ingredients; (9) Patients with a history of immunodeficiency, including HIV test positive, other acquired or congenital immunodeficiency diseases, organ transplantation history, or other immune-related diseases requiring long-term oral hormone therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of acute radiation-induced intestinal injury; | — |
Countries
China
Contacts
Public ContactShang Cai
The Second Affiliated Hospital of Soochow University
Outcome results
None listed