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Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Primary Purpose

Radiotherapy, Toxicity, Diarrhea

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bacillus Licheniformis
Placebo
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiotherapy

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.

Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Outcomes

Primary Outcome Measures

Number of participants with grade 2 or more acute intestinal toxicities
Evaluation using CTCAE version 4.0

Secondary Outcome Measures

Number of participants with grade 2 or more chronic intestinal toxicities
Evaluation using CTCAE version 4.0

Full Information

First Posted
May 31, 2019
Last Updated
January 15, 2021
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03978949
Brief Title
Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)
Official Title
Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Toxicity, Diarrhea, Probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Bacillus Licheniformis
Other Intervention Name(s)
Biscanen cap.
Intervention Description
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo oral tablet
Intervention Description
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
Primary Outcome Measure Information:
Title
Number of participants with grade 2 or more acute intestinal toxicities
Description
Evaluation using CTCAE version 4.0
Time Frame
Adverse effect evaluated at 3 months after radiation therapy
Secondary Outcome Measure Information:
Title
Number of participants with grade 2 or more chronic intestinal toxicities
Description
Evaluation using CTCAE version 4.0
Time Frame
Adverse effect occured after 3 months since end of radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Seok Kim, M.D., PhD.
Phone
82 2 3010 5614
Ext
5614
Email
ysk@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim, M.D., Ph.D.
Phone
82 2 3010 5614
Ext
5614
Email
ysk@amc.seoul.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34530750
Citation
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.
Results Reference
derived

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Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

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