Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
NCT06727773
Summary
This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients with mild cognitive difficulties during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.
Eligibility
Inclusion Criteria: In order to participate in the study a subject must meet all of the eligibility criteria outlined below. * Female * Age ≥ 50 years at the time of consent. * Stage I-III Breast Cancer * Recommended chemotherapy * Enroll prior to 3rd cycle of chemotherapy * Completed at least 1 cycle of standard-of-care neoadjuvant or adjuvant chemotherapy * At least mild self-reported cognitive concerns ≥3 on a 0-10 scale * English-speaking Exclusion Criteria: * Allergy to memantine * Previous chemotherapy (prior to the current regimen), * Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11 * Myocardial infarction in the last 6 months * Cardiovascular or orthopedic limitations to exercise * Severe mental illness (i.e., schizophrenia or bipolar affective disorder) * Current alcohol or drug abuse * Inability to swallow capsules \</= 5mL/min * CrCl \</= 5mL/min
Conditions9
Locations1 site
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NCT06727773