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

NCT07553234 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Stool Sampling

Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).

OTHER

Chia Seeds

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Rita Nanda · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-27
Primary Completion
2030-05-03
Completion
2030-05-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553234 on ClinicalTrials.gov