Probiotics in Radiation-treated Gynecologic Cancer
Not Applicable
Terminated
- Conditions
- Gynecologic CancerGastrointestinal Toxicity
- Interventions
- Dietary Supplement: Capsules probiotic powder and corn starchDietary Supplement: Capsules placebo
- Registration Number
- NCT02351089
- Lead Sponsor
- Probi AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 97
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic low dose Capsules probiotic powder and corn starch capsules containing probiotic powder and corn starch Placebo Capsules placebo capsules containing corn starch Probiotic high dose Capsules probiotic powder and corn starch capsules containing probiotic powder and corn starch
- Primary Outcome Measures
Name Time Method Change in incidence of loose/watery stools Baseline and 10 weeks later
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dept of Oncology
🇸🇪Lund, Sweden