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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

Who can join

Ages 20 and older · All sexes

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

About the study

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.

What is being tested

• Biospecimen Collection (procedure)
• Questionnaire Administration (other)

Sponsor: Mayo Clinic · Participants: 70 · Started: Apr 14, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT05417867

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.