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.
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
Borderline ovarian tumors
Prior allergy or food intolerance to any probiotic product
History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications, active duodenal or gastric ulcer, complete large or small bowel intestinal obstruction, active fistula)
Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) < 1500
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood and vaginal sample collection
Placebo Administration
DrugGiven PO
Probiotic
Dietary supplementGiven PO
Questionnaire Administration
Other interventionAncillary studies
Changes to the gut microbiome composition
Will be assessed by stool samples collected from all patients. Microbe diversity and communities are assessed by 16s ribosomal ribonucleic acid sequencing and metagenomic whole-genome shotgun sequencing. Presence of microbes between responders and non-responders will be compared using Fisher's exact tests and logistic regression. Changes over time will be assessed using generalized linear or logistic regression models accounting for repeated measures, depending on the format of the outcome variable.
Patient compliance with taking probiotic pills
Will be assessed by patient compliance with taking probiotic pills based on the number of pills dispensed versus number of pills remaining at visits, and reason for non-compliance. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, North Carolina \[NC\]), and a p \< 0.05 will be considered statistically significant.
Patient compliance with gut microbiome collection
Will be assessed through number of stool sample kits returned to processing lab versus number of kits given out. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, NC), and a p \< 0.05 will be considered statistically significant.
Patient compliance with vaginal microbiome collection
Will be assessed through number of vaginal microbiome swab sample kits returned to processing lab versus number of kits given out. Compliance will be assessed with patient completion of surveys and return of kits by determining % of kits returned compared to those given to patients and assessing the period of time between when a microbiome kit was provided to a patient and when they returned it. All analyses will be done using SAS (version 9.4, The SAS Institute, Cary, NC), and a p \< 0.05 will be considered statistically significant.
Recurrence free survival (RFS)
Kaplan Meier plots will be created to compare the RFS of patients treated with probiotic versus (vs.) placebo, and RFS will also be assessed based on the presence of specific gut microbes, with median RFS being reported, with 95% confidence intervals.
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Ohio State University Comprehensive Cancer Center
Lead sponsor
Doris Duke Charitable Foundation
Collaborator
Ovarian Cancer Research Alliance
Collaborator
United States Department of Defense
Collaborator
