Evaluating the Association Between Changes in the 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
Mayo Clinic
70 participants
Apr 14, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Metastatic disease
- Concurrent radiation therapy
- Concurrent antibiotic treatment
Interventions
Undergo collection of stool and blood samples
Complete questionnaires
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05417867