Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer
MICRO-VERZ: MICRObiome Changes During VERZenio Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how gut bacteria change early in abemaciclib (Verzenio) treatment and how those changes relate to symptoms like diarrhea. It is for adults with hormone receptor-positive, HER2-negative breast cancer who are starting this treatment. All study tasks are done from home, using mailed stool sample kits and symptom surveys.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have breast cancer confirmed by a tissue test that is hormone receptor-positive (uses hormones to grow) and HER2-negative (does not have high levels of the HER2 protein).
- Plan to start abemaciclib as standard care after initial cancer treatment. Join before starting it or within 7 days of starting.
- Be able to do all or most daily self-care and be out of bed or a chair for more than half of waking hours (ECOG score 0–2).
- If you could become pregnant, agree to use birth control before joining, throughout the study, and for 90 days afterward. Tell your doctor right away if you become pregnant or think you may be pregnant.
- Be able to understand the study and willing to sign a written consent form.
Who can't join
- Be in another trial that tests a treatment if the study doctor thinks it would interfere with this study or its results.
- Have a known gut condition that could greatly affect study tasks or results, such as inflammatory bowel disease (ongoing gut swelling), short bowel syndrome (too little working small intestine), or long-term diarrhea.
- Have a known allergy or intolerance to resistant starch or any ingredient in the study supplement.
- Be pregnant or breastfeeding.
- Have a health, mental health, or social issue that the study doctor thinks would limit your ability to follow study steps.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 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). * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * 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. * Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.
Study sites (1)
VT
- University of Vermont · Burlington, VT 05401Tracy Smith, PhD · Study contact · 1 (802) 656-2021More trials in Burlington