Radiation enteritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed cervical cancer; 2. FIGO stage within 2 weeks before treatment; 3. Include at least the following pretreatment tests and exclude distant metastases: (1) Pelvic contrast-enhanced MRI (preferred) or pelvic contrast-enhanced CT within 4 weeks before radiotherapy; (2) Unenhanced chest CT and upper abdominal CT/ upper abdominal plus urinary ultrasonography within 4 weeks before radiotherapy (unless PET-CT was performed) 4. Aged 18-75 years old; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2; 6. Patients have indications for radiotherapy and are willing to receive radiotherapy; 7. Patients have adequate bone marrow reserves (measured within 14 days before enrollment) : (1) absolute neutrophil count (ANC)=1.5×10^9/L; (2) platelet (PLT)=100×10^9/L; (3) hemoglobin (HGB)=8g/dL (note: it is acceptable to achieve this target by blood transfusion or other interventions); 8. If receiving chemotherapy, patients have good liver and kidney function (measured within 14 days before enrollment) : (1) Serum creatinine (Scr) =2.0mg/dL and creatinine clearance =50ml/min; Creatinine clearance was determined by Cockcroft-Gault method Formula: [(140-age)× weight (Kg)×0.85]/[72×Scr(mg/dL)]; (2) aspartate (AST)=2× upper limit of normal value (ULN); (3) bilirubin =2×ULN; (4) Alkaline phosphatase, magnesium, urea nitrogen and electrolytes can be detected and recorded; 9. Be able to accept research and follow-up procedures; 10. Fully informed and willing to provide written informed consent for the study.
Exclusion criteria
Exclusion criteria: Patients with positive para-aortic lymph nodes or those requiring extended field radiotherapy outside the pelvis; 1. History of other malignant tumors within 5 years (except cured cervical cancer in situ and skin basal cell carcinoma); 2. The presence of other metabolic diseases (such as inflammatory bowel disease, etc.); 3. Previous radiotherapy to the tumor area, resulting in overlapping radiotherapy areas; 4. Complicated with severe and active diseases: (1) unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months; (2) transmural myocardial infarction within the past 6 months; (3) acute bacterial or fungal infection requiring intravenous antibiotics at enrollment; (4) other serious diseases requiring hospitalization at enrollment or excluded from the study; (5) clinical jaundice and/or coagulation defects due to hepatic insufficiency; 5. Use of any antibiotics, prebiotics, probiotics, metabiotics, or immunosuppressants within 4 weeks of fecal collection; 6. Use laxatives regularly in the past 2 weeks; 7. Pregnant or lactating women; 8. Known history of active pulmonary tuberculosis (TB). "If active TB is suspected, chest X-ray, sputum, and clinical examination are required. Bed symptoms and signs were excluded; 9. Patients with untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 500 IU per milliliter or patients with active hepatitis C should be excluded. Inactive HBsAg carriers, patients with treated stable hepatitis B (HBV DNA < 500IU per milliliter), and patients with cured hepatitis C were eligible. Subjects who were HCV antibody-positive were eligible to participate in the study only if they tested negative for HCV RNA. 10. History of human immunodeficiency virus, syphilis and other infections; 11. A known history of psychotropic substance abuse, alcoholism and drug abuse; 12. The patient had cognitive impairment. 13. Previous allergy to cisplatin (except for patients treated with radiotherapy alone); 14. Any situation where the investigator believes that the participant should be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood items; | — |
Countries
China
Contacts
School of Life Sciences, Xiamen University