This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds). The study aims to evaluate the relationship between the gut microbiome (a diverse ecosystem of microorganisms that affects your health and well-being) and treatment-related gastrointestinal toxicities in patients with HR+/HER2- breast cancer receiving abemaciclib plus endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).
In the Fiber Study cohort (Part 2), participants will be advised to consume a standardized daily serving of chia seeds (25g/day) and provided with guidance on how to integrate this into their usual diet.
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Stool Sampling Feasibility
Proportion of enrolled participants who provide serial stool samples during the baseline and on-treatment periods, as recorded by device data and study records.
Time frame: 2 years
Baseline Microbiome-Diarrhea Associations
Correlation between baseline gut microbiome composition and incidence of grade ≥2 diarrhea during abemaciclib therapy, as defined by CTCAE v6.0.
Time frame: 2 years
Microbiome Dynamics and Diarrhea
Correlation between longitudinal changes in gut microbiome composition during abemaciclib therapy and incidence and severity of grade ≥2 diarrhea, as defined by CTCAE v6.0.
Time frame: 2 years
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