Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Phase 3

Recruiting

• Conditions: Diarrhea; Probiotics; Radiotherapy; Toxicity
• Interventions: Drug: Bacillus Licheniformis; Drug: Placebo

• Registration Number: NCT03978949
• Lead Sponsor: Asan Medical Center

Brief Summary

In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study Start: 2019-06-01
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
• Over 20 years of age
• Eastern Cooperative Oncology Group (ECOG) score 0-2
• Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
• Appropriate values of kidney function within 6 months after enrollment Creatinin < 2.0 ng/dL
• Appropriate values of liver function within 6 months after enrollment Total bilirubin < 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase < 2.5 times upper limit normal range.
• Willing to provide informed written consent

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Exclusion Criteria

• History of pelvic irradiation
• Double primary cancer other than skin/thyroid cancer
• Combined serious morbidity
• Experience of other clinical trial within 1 month.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Bacillus Licheniformis	Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
Placebo	Placebo	Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Primary Outcome Measures

Name	Time	Method
Number of participants with grade 2 or more acute intestinal toxicities	Adverse effect evaluated at 3 months after radiation therapy	Evaluation using CTCAE version 4.0

Secondary Outcome Measures

Name	Time	Method
Number of participants with grade 2 or more chronic intestinal toxicities	Adverse effect occured after 3 months since end of radiation therapy	Evaluation using CTCAE version 4.0

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of