Radiation Enteritis
Conditions
Interventions
Experimental group 2:Treatment with 100 mg thalidomide nanosuspension enema
Experimental group 2:Oral 100 mg thalidomide tablets
Placebo group:60ml 0.1% HA enema
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–75 years (both genders eligible); 2.Pathologically confirmed abdominal or pelvic malignancies (cervical cancer, rectal cancer, prostate cancer, etc.) receiving radical radiotherapy or postoperative adjuvant radiotherapy in our department (total dose >= 45 Gy); 3.For prophylactic patients: No grade >= 2 radiation enteritis (RTOG criteria) before radiotherapy or within 1 week after initiation of radiotherapy; 4.For therapeutic patients: Grade >= 2 acute radiation enteritis occurring during radiotherapy (meeting at least one of the following: diarrhea >= 4 times/day, or abdominal pain/hematochezia requiring pharmacological intervention); 5.Adequate hematopoietic function and general condition (white blood cell count >2.5×10?/L, platelet count >50×10?/L, bilirubin = 70, life expectancy >12 months; 8.Ability to comply with the study protocol, commitment to timely medication, completion of follow-up visits and examinations (including endoscopic evaluation); 9.Written informed consent signed by the patient personally.
Exclusion criteria
Exclusion criteria: 1. Pregnant/lactating women or not taking highly effective contraceptive measures. 2. Previous pelvic radiotherapy. 3. History of malignant tumors, chemotherapy, and radiotherapy, except for cured skin cancer. 4. History of immunodeficiency, including positive HIV test or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy; 5. Previous severe cardiovascular and cerebrovascular diseases (NYHA cardiac function = class II, myocardial infarction or unstable arrhythmia within 6 months); 6. Have a history of other important organ (system) diseases, such as: inflammatory bowel disease (Crohn's disease/ulcerative colitis), intestinal obstruction, active gastrointestinal infection and urinary system disease. 7. Those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, whose clinical severity may be judged by the investigator to be able to prevent the signing of informed consent or affect the patient's compliance with drug treatment 8. Individuals allergic to any investigational drug components; history of >= Grade 2 peripheral neuropathy (CTCAE v5.0); history of deep vein thrombosis. 9. Known significant active infection, or deemed by the investigator to have significant hematologic, renal, metabolic, gastrointestinal, endocrine dysfunction or metabolic disorders, or other serious uncontrolled comorbidities; 10. Subjects whose baseline blood routine and biochemical indicators do not meet the anti-tumor criteria; 11. Those who have received any of the following treatments within 4 weeks prior to radiotherapy, including antibiotics, probiotics, prebiotics, hormones, immunosuppressants, etc.; 12. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation Enteritis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete mucosal healing rate; | — |
Countries
China
Contacts
Public ContactMadaiyuan
Oncology Department
Outcome results
None listed