Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978949
• Other study ID #: S2019-0657-0003
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: Young Seok Kim, M.D., PhD.
• Phone: 82 2 3010 5614
• Email: ysk[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Probiotics
• Radiotherapy
• Toxicity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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