Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont Medical Center
Study ID
NCT07406594
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Resistant Potato Starch — DIETARY_SUPPLEMENT
    Participants randomized to the resistant starch intervention will receive a resistant starch dietary supplement administered orally. The supplement will be taken during early abemaciclib therapy according to study instructions. Abemaciclib is administered as standard of care and is not altered by study participation.
  • Placebo control — DIETARY_SUPPLEMENT
    Participants randomized to the placebo intervention will receive a placebo dietary supplement administered orally as a powder mixed with a beverage. The supplement will be taken during early abemaciclib therapy according to study instructions. Abemaciclib is administered as standard of care and is not altered by study participation.

Study Details

Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms. The purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely. Information gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.

Key Dates

Start date
Oct 31, 2027
Status verified
Feb 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Resistant Starch Intervention
    Participants randomized to this arm will receive resistant starch powder as a dietary supplement during early abemaciclib therapy. The supplement will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.
  • Placebo Comparator: Placebo Supplementation (Control Arm)
    Participants randomized to this arm will receive a placebo powder as a dietary supplement during early abemaciclib therapy. The placebo will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.

Primary Outcome Measure

Recruitment rate [ Time Frame: From study opening through completion of enrollment (approximately 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VermontBurlingtonVermont05401
Tracy Smith, PhD
1 (802) 656-2021

Find similar trials in Burlington, VT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Vermont· Burlington, VT

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