Probiotics in Radiation-treated Gynecologic Cancer

NCT ID: NCT02351089

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Gastrointestinal Toxicity Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

capsules containing corn starch

Group Type PLACEBO_COMPARATOR

Capsules placebo

Intervention Type DIETARY_SUPPLEMENT

Capsules

Probiotic low dose

capsules containing probiotic powder and corn starch

Group Type ACTIVE_COMPARATOR

Capsules probiotic powder and corn starch

Intervention Type DIETARY_SUPPLEMENT

Probiotic high dose

capsules containing probiotic powder and corn starch

Group Type ACTIVE_COMPARATOR

Capsules probiotic powder and corn starch

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Capsules placebo

Capsules

Intervention Type DIETARY_SUPPLEMENT

Capsules probiotic powder and corn starch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dept of Oncology

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ProRad

Identifier Type: -

Identifier Source: org_study_id

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