Gastrointestinal Toxicity, Gynecologic Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCapsules placebo
Capsules
DIETARY_SUPPLEMENTCapsules probiotic powder and corn starch
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in incidence of loose/watery stools | Baseline and 10 weeks later |
Countries
Sweden
Outcome results
None listed