Evaluating the Association Between Changes in the Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer

Description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.

II. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.

III. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.

OUTLINE: This is an observational study.

Patients undergo collection of stool and blood samples and complete questionnaires on study.