Diarrhea, Probiotics, Radiotherapy, Toxicity
Conditions
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.
Interventions
DRUGBacillus Licheniformis
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
DRUGPlacebo
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with grade 2 or more acute intestinal toxicities | Adverse effect evaluated at 3 months after radiation therapy | Evaluation using CTCAE version 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with grade 2 or more chronic intestinal toxicities | Adverse effect occured after 3 months since end of radiation therapy | Evaluation using CTCAE version 4.0 |
Countries
South Korea
Contacts
Primary ContactYoung Seok Kim, M.D., PhD.
Outcome results
None listed