This clinical trial studies how the gut microbiome (the natural bacteria and other microbes living in the digestive system) may affect the side effects of abemaciclib and whether increasing dietary fiber with chia seeds changes the gut microbiome and helps reduce diarrhea in patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer receiving abemaciclib. Abemaciclib is a Food and Drug Administration-approved drug for the treatment of HR+/HER2- breast cancer. Many patients who take it develop diarrhea, but researchers do not fully understand why. In this trial, researchers first plan to collect frequent stool samples from patients before and during abemaciclib treatment to learn whether differences in the microbiome are linked to side effects such as diarrhea. They then plan to have patients increase dietary fiber with chia seeds before starting abemaciclib to see whether there are changes to the microbiome and/or side effects. Chia seeds are the edible seeds of the flowering plant Salvia hispanica (chia) which contain high levels of dietary soluble fiber and are used as a nutritional supplement. When used as a nutritional supplement, chia seeds may balance the gut microbiome which may reduce diarrhea when starting abemaciclib. Researchers hope that this trial will help them understand how the gut microbiome and dietary fiber affect side effects of abemaciclib and ultimately reduce diarrhea in patients with HR+/HER2- breast cancer receiving abemaciclib.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07553234.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Rita Nanda
Phone: 773-834-2756
PRIMARY OBJECTIVE:
I. To determine the feasibility of prospectively collecting baseline and on treatment serial stool samples in patients with HR+/HER2- breast cancer receiving abemaciclib.
SECONDARY OBJECTIVES:
I. To characterize baseline differences in gut microbiome composition and assess associations with the incidence and severity of ≥ grade 2 diarrhea in patients with HR+/HER2- breast cancer receiving abemaciclib.
II. To evaluate dynamic on-treatment changes in gut microbiome composition during abemaciclib and correlate with the incidence and severity of ≥ grade 2 diarrhea.
III. To determine the feasibility and tolerability of a 2 week pre-abemaciclib chia seed intervention with concurrent stool sampling.
IV. To evaluate the feasibility of studying the human gut microbiome in animal models of breast cancer by recapitulating the microbiome of patients in animals through fecal transplantation.
V. To assess whether the circulating ribonucleic acid (RNA) and metabolomics profiled from plasma can be used as a surrogate for microbial composition and/or development of toxicity.
OUTLINE: Patients are assigned to 1 of 2 parts.
PART 1: Patients undergo blood sample collection at baseline, 4 weeks after starting abemaciclib, as well as optionally 3 months after starting abemaciclib and at the time of a toxicity warranting dose reduction or discontinuation. Patients also undergo continuous at-home stool sample collection from 2 weeks prior to abemaciclib to 4 weeks after starting abemaciclib and manual stool sample collection 2 weeks prior to abemaciclib and 4 weeks after starting abemaciclib. Additionally, patients complete a dietary/lifestyle questionnaire at baseline, daily check ins from 2 weeks prior to abemaciclib to 4 weeks after starting abemaciclib, and an end of study experience survey 4 weeks after starting abemaciclib.
PART 2: Patients consume a standardized daily serving of chia seeds integrated into their usual diet for 2 weeks prior to abemaciclib in the absence of unacceptable toxicity. Additionally, patients receive educational material and instructions on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorRita Nanda
