This clinical trial evaluates the impact of a dietary intervention, Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND), on mental (cognitive) changes in women with triple negative breast cancer (TNBC) undergoing active treatment. Cancer-related cognitive impairment (CRCI) is one of the most common and serious side effects of treatment such as chemotherapy and women with TNBC may have more severe CRCI than other patients. The MIND diet includes foods, such as leafy greens, beans, whole grains, non-dried fish and olive oil, that have been linked to improved brain health. Data has shown that following the MIND diet pattern may slow the rate of cognitive decline. The MIND diet intervention may prevent cognitive changes in women with TNBC undergoing active treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT06582615.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Tonya Orchard
Phone: 614-292-7241
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer [BC]) versus (vs.) general health curriculum (GHC) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage I-III TNBC.
II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.
EXPLORATORY OBJECTIVE:
I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus later participation in the dietary intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.
ARM II: Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorTonya Orchard
