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

Study acronym: GEMMA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Dec 27, 2026 to Sep 21, 2026
    • Eligibility criteria shortened, about 14 words
    • Site details revised
  2. Secondary endpoints: details revised at 2 of 2 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07553234
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov