Probiotics in Radiation-treated Gynecologic Cancer (ProRad)

Probi AB

Status: Terminated

Conditions: Gynecologic Cancer; Gastrointestinal Toxicity

Treatments: Dietary Supplement: Capsules probiotic powder and corn starch; Dietary Supplement: Capsules placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351089

ProRad

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

capsules containing corn starch

Treatment:

Dietary Supplement: Capsules placebo

Probiotic low dose

Active Comparator group

Description:

capsules containing probiotic powder and corn starch

Treatment:

Dietary Supplement: Capsules probiotic powder and corn starch

Probiotic high dose

Active Comparator group

Description:

capsules containing probiotic powder and corn starch

Treatment:

Dietary Supplement: Capsules probiotic powder and corn starch