Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07553234
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stool Sampling — OTHER
    Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).
  • Chia Seeds — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 27, 2026
Status verified
Apr 2026
Primary completion
May 3, 2030
Completion
May 3, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Observational Cohort
    Enrolled patients with early or advanced HR+/HER2- breast cancer starting abemaciclib as per standard of care to characterize the baseline composition and longitudinal dynamics of the gut microbiome before and during treatment. Stool samples will be collected continuously using the GutLab platform, alongside clinical toxicity assessments, with a focus on identifying microbial signatures associated with the development and severity of diarrhea. No intervention will be administered.
  • Experimental: Dietary Intervention Cohort
    Enrolled patients with early-stage HR+/HER2- breast cancer. A 2-week chia seed intervention will be administered prior to initiation of abemaciclib. The goal of this high fiber intervention is to favorably modulate the gut microbiome by supporting a more diverse microbiome and reducing the risk of inflammation and dysbiosis.

Primary Outcome Measure

Stool Sampling Feasibility [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Rita Nanda (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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