Study of Probiotic Effects on Gut and Vaginal Microbiome in Women With Advanced or Recurrent Ovarian Cancer Receiving Platinum Chemotherapy

What this Trial Is About

Researchers are studying the effects of a probiotic intervention on the gut and vaginal microbiomes of patients with advanced or recurrent ovarian cancer undergoing platinum chemotherapy. This trial aims to understand how probiotics may influence the microbiome composition, quality of life, symptoms, chemotherapy toxicity, and oncologic outcomes such as recurrence-free and overall survival. Participants are randomly assigned to receive either a probiotic or a placebo orally twice daily starting within seven days of their first platinum chemotherapy cycle and continuing until seven days after their sixth cycle. Each chemotherapy cycle lasts 21 days, with up to six cycles planned unless disease progression or unacceptable toxicity occurs. Throughout the study, blood and vaginal samples are collected, and questionnaires are administered to assess diet, symptoms, and other related factors. During the trial, participants undergo regular microbiome sample collections within one week before or after cycles 1, 3, and 6 of chemotherapy. Researchers monitor patient compliance with the probiotic or placebo intake and sample collections. They also assess chemotherapy-related outcomes, including toxicity, morbidity, infection rates after surgery, and changes in serum markers. The study duration corresponds to the chemotherapy cycles plus follow-up to evaluate survival outcomes and microbiome changes.

Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy