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RECRUITINGOBSERVATIONAL

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

Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida - At least 20 years of age - Last chemotherapy more than 3 years ago - Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies Who Should NOT Join This Trial: - Metastatic disease - Concurrent radiation therapy - Concurrent antibiotic treatment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida * At least 20 years of age * Last chemotherapy more than 3 years ago * Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies Exclusion Criteria: * Metastatic disease * Concurrent radiation therapy * Concurrent antibiotic treatment

Treatments Being Tested

PROCEDURE

Biospecimen Collection

Undergo collection of stool and blood samples

OTHER

Questionnaire Administration

Complete questionnaires

Locations (5)

Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health System in Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States