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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Metastatic disease
Concurrent radiation therapy
Concurrent antibiotic treatment
Trial population
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, Minnesota, and Mayo Clinic Florida.
Trial design
Case-only
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of stool and blood samples
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Number of patients approached
Assessed using descriptive statistics.
Number of patients enrolled
Assessed using descriptive statistics.
Number of patients who completed the questionnaires at both assessments
Assessed using descriptive statistics.
Number of patients who provided stool samples at both assessments
Assessed using descriptive statistics.
Sponsors and contacts
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