Probiotics in Radiation-treated Gynecologic Cancer

Gynecologic Cancer Clinical Trial

— ProRad  

Official title:

Probiotics in Radiation-treated Gynecologic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02351089
• Other study ID #: ProRad
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Toxicity
• Gynecologic Cancer

Intervention

Dietary Supplement:
• Capsules placebo
Capsules
• Capsules probiotic powder and corn starch

Locations

Country	Name	City	State
Sweden	Dept of Oncology	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incidence of loose/watery stools		Baseline and 10 weeks later