Radioactive intestinal injury
Conditions
Interventions
Probiotic group:Probiotics assisted therapy
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 unlimited; 2. Cervical cancer patients with confirmed pathological diagnosis who have been admitted to our department for radical radiotherapy or postoperative adjuvant radiotherapy; 3. Hematopoietic function and systemic condition of the patient were acceptable (leukocyte > 2.5*109/L, platelet > 50*109/L, bilirubin not exceeding 1.5 times of the upper limit of normal, liver function glutamic-pyruginous transaminase and glutamic-oxalacetic transaminase not exceeding 2.5 times of the upper limit of normal, renal function creatinine not exceeding 1.5 times of the upper limit of normal); 4. No congestive heart failure, unstable angina pectoris, or unstable arrhythmia occurred in the past 6 months; 5. The patients' activity status was evaluated by the Eastern Cooperative Oncology Group (ECOG) score (0-1), functional status was evaluated by Karnofsky (KPS) score (=70), and life expectancy was evaluated (> 12 months); 6. Able to adhere to the programme for the study period; 7. The patient can sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women. 2. History of malignant tumor, chemotherapy and radiotherapy, except for cured skin cancer; 3. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's compliance with medication. 4. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmias requiring medical intervention, or a history of myocardial infarction within the last 12 months. 5. Immunosuppressive therapy is needed for organ transplantation. 6. A major active infection is known, or a major disorder of blood, kidney, metabolic, gastrointestinal, endocrine, or metabolic function, or other serious uncontrolled concomitant disease is determined by the investigator. 7. The subjects' baseline blood routine and biochemical indexes did not meet the anti-tumor index standards. 8. Allergic to any investigational drug ingredient. 9. People with a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy. 10. Have a clear history of diseases of other important organs (systems), intestinal diseases (inflammatory bowel diseases, etc.) and urinary diseases; 11. Patients who have received any of the following treatments, including antibiotics, probiotics, prebiotics, hormones, immunosuppressants, etc., within 4 weeks before fecal sampling; 12. Received chemotherapy, targeted therapy, radiotherapy or immunotherapy within 2 weeks before fecal sampling; Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT evaluation of gastrointestinal (acute) toxicity (RECIST1.1 criteria);Microbial composition and metabolite expression in feces; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other toxic reactions (RECIST1.1, CTCAE 4.0 standard);Tumor local control rate (LR);Disease-free survival rate (DFS);Overall survival rate (OS); | — |
Countries
China
Contacts
Public ContactShang cai
The Second Affiliated Hospital of Soochow University
Outcome results
None listed