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

RECRUITINGSponsored by Mayo Clinic
Actively Recruiting
SponsorMayo Clinic
Started2021-04-14
Est. completion2026-09
Eligibility
Age20 Years+
Healthy vol.Accepted
Locations5 sites

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

Age: 20 Years+Healthy volunteers accepted
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

Conditions6

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Breast CancerCancerChemotherapy-Related Nausea and/or VomitingEarly Stage Breast Carcinoma

Locations5 sites

Arizona

1 site
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Florida

1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980

Minnesota

3 sites
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office855-776-0015mayocliniccancerstudies@mayo.edu
Mayo Clinic Health System in Mankato
Mankato, Minnesota, 56001
Clinical Trials Referral Office612-624-2620mayocliniccancerstudies@mayo.edu
Mayo Clinic in Rochester
Rochester, Minnesota, 55905

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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