Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study

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.

Study Overview

• Status: Recruiting
• Conditions: Diarrhea; Probiotics; Toxicity; Radiotherapy
• Intervention / Treatment: Drug: Bacillus Licheniformis; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Young Seok Kim, M.D., PhD.; Phone Number: 5614 82 2 3010 5614; Email: ysk@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Young Seok Kim, M.D., Ph.D.; Phone Number: 5614 82 2 3010 5614; Email: ysk@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.	Drug: Bacillus Licheniformis; Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.; Other Names: Biscanen cap.
Placebo Comparator: Placebo; Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.	Drug: Placebo; Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.; Other Names: Placebo oral tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Young Seok Kim, M.D., Ph.D., Asan Medical Center

Publications and helpful links

General Publications

• Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: S2019-0657-0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No