A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy
Ohio State University Comprehensive Cancer Center
Summary
This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.
Description
PRIMARY OBJECTIVE: I. To evaluate changes to the gut microbiome composition in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy. SECONDARY OBJECTIVES: I. Compliance with probiotic intervention in ovarian cancer patients during chemotherapy. II. Compliance with gut microbiome collection in ovarian cancer patients during chemotherapy. III. Compliance with vaginal microbiome collection in ovarian cancer patients during chemotherapy. IV. Recurrence free survival (RFS). V. Overall survival (OS). EXPLORATORY OBJECTIVES: I. To evaluate…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form translated in their native language and have their native language translator present for consenting process * Age \> 18 years old * Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin, carboplatin containing regimens) * Agreeable to participate in all research activities defined in the study * Agreeable to not take any other probiot…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and vaginal sample collection
- DrugPlacebo Administration
Given PO
- Dietary SupplementProbiotic
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio