NCT03978949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

May 31, 2019

Last Update Submit

January 15, 2021

Conditions

RadiotherapyToxicityDiarrheaProbiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants with grade 2 or more chronic intestinal toxicities

    Adverse effect occured after 3 months since end of radiation therapy

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bacillus LicheniformisDRUG

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

Also known as: Biscanen cap.
Probiotics
PlaceboDRUG

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

Also known as: Placebo oral tablet
Placebo

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (2)

  • Jo YY, Kim YJ, Lee SH, Kim YS. Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial. Curr Oncol. 2024 Oct 1;31(10):5889-5895. doi: 10.3390/curroncol31100438.

    PMID: 39451742DERIVED

  • 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.

    PMID: 34530750DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Young Seok Kim, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Seok Kim, M.D., PhD.

CONTACT

82 2 3010 5614ysk@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 7, 2019

Study Start

June 1, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2024

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

KR(1)