NCT02351089TerminatedNot Applicable
Probiotics in Radiation-treated Gynecologic Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Probi AB
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Change in incidence of loose/watery stools
Study Overview
Brief Summary
The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
- •Age, older than 18 years old.
- •Agreement for participation in the study by signed written informed consent.
Exclusion Criteria
- •Previously treated with irradiation of the pelvic area.
- •Reluctance to refrain from using other probiotic products during the participation in the study.
Outcomes
Primary Outcomes
Change in incidence of loose/watery stools
Time Frame: Baseline and 10 weeks later
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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