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Gut Health and Breast Cancer Treatment Toxicities Study

This study is looking into the connection between your gut health (the diverse community of microorganisms in your digestive system) and stomach-related side effects from breast cancer treatments. Specifically, it focuses on patients with HR+/HER2- breast cancer who are taking abemaciclib plus endocrine therapy. The study will first observe participants, collecting stool samples using a device called GutLab. Later, a small group will be asked to add chia seeds to their diet. We want to see if these chia seeds can help with gut health. To join, you must be at least 18 years old and have a specific type of HER2-negative breast cancer. The study is currently unclear on its recruitment status and aims to assess the feasibility of stool sampling over two years.

Study design
This study will enroll 20 participants and has two parts: an observational study followed by a small interventional pilot study.
What's involved
You would provide stool samples continuously using a GutLab device. If you are in the second part of the study, you would also consume 25g of chia seeds daily.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for stool sampling feasibility is measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07553234

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

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
University of Chicago
~20 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Stool SamplingChia Seeds

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stool Sampling Feasibility
Measured over 2 years

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaESR1 GenePGR Gene

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Rita Nanda · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Clinical Trials Intake
[email protected]
855-702-8222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be willing and able to provide written informed consent for the trial
Be a male or female subject 18 years of age on day of signing informed consent.
Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:
Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as \>1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2).
Be willing to provide mandatory stool samples at baseline and on treatment.
The Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion

Patients who are pregnant or breast-feeding
Current use of any investigational agents
Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function
History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.

What this trial measures

  • Stool Sampling Feasibility2 years

    Proportion of enrolled participants who provide serial stool samples during the baseline and on-treatment periods, as recorded by device data and study records.