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This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.
PRIMARY OBJECTIVES: I. To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy. II. To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy. III. To examine associations between microbial composition functional profiles at T1 and T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints. IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2, T3 and T4. OUTLINE: This is an observational study. Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.
Age
20 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
March 22, 2024
Primary Completion Date
November 18, 2024
Completion Date
November 18, 2024
Last Updated
June 25, 2025
9
ACTUAL participants
Non-Interventional Study
OTHER
Lead Sponsor
Mayo Clinic
NCT05673200
NCT04704661
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