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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch Intervention | Experimental | 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. |
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| Placebo Supplementation (Control Arm) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Feasibility will be assessed by the proportion of eligible participants who enroll in the study out of those approached for participation. | From study opening through completion of enrollment (approximately 12 months) |
| Participant retention | Feasibility and acceptability will be assessed by the proportion of enrolled participants who complete the intervention period and final study assessments. | Through end of intervention (6 weeks) |
| 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. | During the 6-week intervention |
| Completion of study procedures | Feasibility will be assessed by the proportion of participants who complete protocol-specified stool sample collections and questionnaires. | Baseline through end of intervention (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Week 6 of abemaciclib therapy |
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Inclusion Criteria:
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Smith, PhD | Contact | 1 (802) 656-2021 | tracy.smith@med.uvm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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. |
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| 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. | Baseline through Week 6 of abemaciclib therapy |
| 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. | Baseline through Week 6 of abemaciclib therapy |
| D017437 |
| Skin and Connective Tissue Diseases |