Study of Gut Microbiome Changes and Their Link to Fatigue and Nausea in Early Stage Breast Cancer Patients Undergoing Chemotherapy

What this Trial Is About

Researchers are investigating how changes in the gut bacteria microbiome might be linked to fatigue and chemotherapy-induced nausea CIN in women with early stage breast cancer. Since patients receiving chemotherapy often experience these symptoms, this observational study aims to explore why some patients have more fatigue and nausea than others, focusing on the role of the gut microbiome. The study is supported by Mayo Clinic and collects data before and after chemotherapy treatment. Participants provide stool and blood samples before starting chemotherapy and again 3 to 5 days after chemotherapy begins. They also complete questionnaires about their symptoms, food intake, exercise, and other health factors. The study observes changes in gut bacteria composition and metabolites to understand their connection to fatigue and CIN during chemotherapy. During the study, patients are asked to complete questionnaires and provide biological samples at two time points before chemotherapy and shortly after treatment starts. Researchers monitor the bacterial makeup of stool samples and compare demographic and clinical characteristics between patients who do and do not report fatigue or nausea. The study tracks recruitment, retention, and the completion of study assessments over up to 24 months, aiming to better understand symptom differences related to chemotherapy.

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