Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Vermont Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.
Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Disqualifiers
Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.
Known allergy or intolerance to resistant starch or any component of the study supplement.
Pregnant or breastfeeding individuals.
Trial design
Design model
Parallel
Treatments tested in this trial
Resistant Potato Starch
Dietary supplementParticipants 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 supplementParticipants 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.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Resistant Starch InterventionExperimental treatment 1 intervention
Group B: Placebo Supplementation (Control Arm)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Feasibility will be assessed by the proportion of eligible participants who enroll in the study out of those approached for participation.
Time frame
From study opening through completion of enrollment (approximately 12 months)2
Participant retention
Feasibility and acceptability will be assessed by the proportion of enrolled participants who complete the intervention period and final study assessments.
Time frame
Through end of intervention (6 weeks)3
Supplement adherence
Feasibility will be assessed by participant adherence to the assigned supplement, measured as the proportion of prescribed doses taken during the intervention period.
Time frame
During the 6-week intervention4
Completion of study procedures
Feasibility will be assessed by the proportion of participants who complete protocol-specified stool sample collections and questionnaires.
Time frame
Baseline through end of intervention (6 weeks)Secondary outcomes
1
Change in Gut Microbial Community Composition During Early Abemaciclib Therapy
Changes in gut microbial community composition will be assessed using stool samples collected at baseline and during early abemaciclib therapy. Microbiome profiles will be compared over time and between intervention groups to characterize longitudinal changes associated with treatment.
Time frame
Baseline through Week 6 of abemaciclib therapy2
Correlation between gut microbiome diversity and gastrointestinal symptom severity
Correlation between gut microbiome alpha diversity measured from stool samples using 16S rRNA gene sequencing (Shannon diversity index, unitless) and gastrointestinal symptom severity measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) gastrointestinal symptom items (score range 0-4 per item). Correlation coefficients will be calculated to assess the relationship between microbiome diversity and symptom severity during early abemaciclib therapy.
Time frame
Baseline through Week 6 of abemaciclib therapy3
Differences in Gut Microbial Community Composition Between Resistant Starch and Placebo Groups
Differences in gut microbial community composition and temporal patterns will be explored between participants randomized to resistant starch supplementation and those receiving placebo using stool samples collected at multiple time points during early abemaciclib therapy.
Time frame
Baseline through Week 6 of abemaciclib therapySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: