This clinical trial studies the impact of a combined intermittent fasting and exercise intervention on metabolic markers in patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery (unresectable). This trial is to study whether a combined program of moderate-intensity exercise and prolonged overnight fasting, or waiting at least 13 hours between the last meal of the night and the first meal the next day, is feasible in women with hormone receptor-positive metastatic breast cancer initiating endocrine therapy in combination with a CDK4/6 inhibitor or alpelisib.
Additional locations may be listed on ClinicalTrials.gov for NCT04708860.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of a prolonged overnight fasting and moderate-intensity exercise intervention in women with hormone receptor-positive metastatic breast cancer initiating endocrine therapy in combination with CDK4/6 inhibitor or alpelisib.
SECONDARY OBJECTIVES:
I. To evaluate changes in fasting glucose, insulin, insulin resistance, hemoglobin A1c and other metabolic, inflammatory, and immune biomarkers in women treated with endocrine therapy plus a CDK4/6 inhibitor or alpelisib who are participating in a prolonged overnight fasting and exercise intervention.
II. To evaluate changes in quality of life and other patient reported outcomes over the course of a 12-week prolonged overnight fasting (POF) and exercise intervention.
III. To explore differences in changes in metabolic markers over the course of a 12-week POF and exercise intervention by treatment group (alpelisib versus [vs] CDK4/6 inhibitor).
OUTLINE:
Patients complete POF (including restriction of consumption of calorie-containing food/drinks after 8pm, with a minimum of 13 hours after the fasting start before resuming eating the next day) at least 6 days per weeks over 12 weeks. Patients also complete aerobic exercise over 120 minutes and 2 virtual strength training classes over 35-45 minutes every week for 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer Ann Ligibel
