Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Asan Medical Center

Status and phase: Enrolling; Phase 3

Conditions: Diarrhea; Radiotherapy; Probiotics; Toxicity

Treatments: Drug: Placebo; Drug: Bacillus Licheniformis

Study type: Interventional

Funder types: Other

Identifiers

NCT03978949

S2019-0657-0003

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Drug: Bacillus Licheniformis

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo