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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03978949
Other study ID # S2019-0657-0003
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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