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To study the correlation between the characteristics of intestinal flora and the adverse reactions of radiotherapy in patients with cervical cancer and colorectal cancer

To study the correlation between the characteristics of intestinal flora and the adverse reactions of radiotherapy in patients with cervical cancer and colorectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077154
Enrollment
Unknown
Registered
2023-10-31
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation enteritis

Interventions

Cervical cancer and colorectal cancer radiotherapy group:None

Sponsors

School of Life Sciences, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Blood items;

Countries

China

Contacts

Public ContactHao Guo

School of Life Sciences, Xiamen University

guohaojkjk@163.com+86 137 9378 9898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026