TerminatedNCT02351089ProRadUpdated Mar 5, 2020

Probiotics in Radiation-treated Gynecologic Cancer

An interventional study of Capsules placebo and Capsules probiotic powder and corn starch in Gastrointestinal Toxicity and Gynecologic Cancer, sponsored by Probi AB. Terminated at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-05.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Why this study was terminated

Slow recruitment

Phase: Not applicable
Study type: Interventional
Enrollment: 97
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Conditions studied

Gastrointestinal Toxicity
Gynecologic Cancer

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts 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

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 97 participants (actual)

Study arms

Placebo comparator
Placebo
capsules containing corn starch
Dietary Supplement: Capsules placebo
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

Interventions

Dietary supplementCapsules placebo
Capsules
Dietary supplementCapsules probiotic powder and corn starch

What researchers measure

Primary outcomes

Change in incidence of loose/watery stools
Time frame: Baseline and 10 weeks later

Study locations

1 site

Dept of Oncology
Lund, Sweden

Registry details

Key details

Study ID: NCT02351089
Lead sponsor: Probi AB
Responsible party: Sponsor
First posted: Jan 30, 2015
Start date: Feb 2015
Primary completion: Dec 2018
Completion: Dec 2019
Last update: Mar 5, 2020

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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