Probiotics in Radiation-treated Gynecologic Cancer

Not Applicable

Terminated

• Conditions: Gynecologic Cancer; Gastrointestinal Toxicity

• 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

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-05

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

Primary Outcome Measures

Name	Time	Method
Change in incidence of loose/watery stools	Baseline and 10 weeks later

Trial Locations

Locations (1)

Dept of Oncology; 🇸🇪 Lund, Sweden