Saccharomyces boulardii for Preventing Acute Radiation Enteritis in Uterine Cervical Cancer

Phase 2

Completed

• Conditions: terine cervical cancerAcute radiation enteritisGut microbiota dysbiosis; Uterine Cervical Neoplasm; Cervical cancer; Probiotic; Saccharomyces boulardii; S boulardii; Radiotherapy; Microbiota

• Registration Number: TCTR20210204013
• Lead Sponsor: Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Study Completion: 2023-09-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of grade 2 or higher diarrhea 1 week before radiotherapy, weekly during the radiotherapy, and 1 month after radiotherapy CTCEA version 5

Secondary Outcome Measures

Name	Time	Method
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