Probiotics in Radiation-treated Gynecologic Cancer (ProRad)

March 3, 2020 updated by: Probi AB
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Dept of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
capsules containing corn starch
Dietary supplement: Capsules placebo
Capsules
Active Comparator: Probiotic low dose
capsules containing probiotic powder and corn starch
Dietary supplement: Capsules probiotic powder and corn starch
Active Comparator: Probiotic high dose
capsules containing probiotic powder and corn starch
Dietary supplement: Capsules probiotic powder and corn starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in incidence of loose/watery stools
Time Frame: Baseline and 10 weeks later
Baseline and 10 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ProRad

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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