Uterine cervical cancer Acute radiation enteritis Gut microbiota dysbiosis Uterine Cervical Neoplasm Cervical cancer Probiotic Saccharomyces boulardii S boulardii Radiotherapy Microbiota
Conditions
Interventions
Saccharomyces boulardii probiotic capsule which contains 250 mg of lyophilized Saccharomyces boulardii CNCM I-745 per capsule, will be prescribed to take 1 capsule in the morning and 1 capsule in the
Experimental Drug,Placebo Comparator Drug
Saccharomyces boulardii probiotic,Placebo
Sponsors
Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. ECOG performance status 0-1 2. Locally advanced uterine cervical cancer FIGO version 2018 stage IB3, IIA2, IIB, IIIA, IIIB, IIIC1, IVA (bladder only) 3. Histologically confirmed of squamous cell carcinoma, adenocarcinoma, adenosquamous of cervix 4. Baseline laboratory tests are in the normal ranges. (White blood cell not less than 3000 per mL, Absolute neutrophil not less than 1500 per mL, Creatinine clearance not less than 50 mL per min) 5. The participant or legal representative provides the written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. Any previous pelvic radiotherapy 2. Prior diagnosis of Crohn disease or ulcerative colitis 3. Patients who are pregnant or lactating 4. Metastatic disease to paraaortic lymph node area, distant metastatic disease or locoregional recurrence. 5. Prior allergy to probiotic or medication(s) used in the study. 6. Active autoimmune disease that required medication within 2 years. 7. Use of immune suppressive medication within 2 months before accrual. 8. Known disease or condition that would interfere with the cooperation of the study. 9. Poor communication or cooperation as the treating physician judgement 10. Rectal invasion of primary tumor 11. Paraaortic lymph node metastasis 12. Prior chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of grade 2 or higher diarrhea 1 week before radiotherapy, weekly during the radiotherapy, and 1 month after radiotherapy CTCEA version 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of grade 2 or higher acute gastrointestinal side effects 1 week before radiotherapy, weekly during the radiotherapy, and 1 month after radiotherapy CTCEA version 5,Mean C-reactive protein value 1 week before radiotherapy, weekly during the radiotherapy, and 1 month after radiotherapy C reactive protein,Mean NLR 1 week before radiotherapy, weekly during the radiotherapy, and 1 month after radiotherapy ratio of %neutrophil and %lymphocyte in CBC,Gut microbiota profile 1 week before radiotherapy, and at the end of radiotherapy 16s rRNA V3-V4 amplicon-based next generation sequencing) from patient feces | — |
Countries
Thailand
Contacts
Public ContactPooriwat Muangwong
Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed