Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
UNC Lineberger Comprehensive Cancer Center
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 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.
Description
There are 4 million breast cancer survivors in the U.S. and an estimated 1.4 million suffer from long-term cognitive deficits from cancer treatment. Compared to other cancers and treatments, cognitive decline has been most robustly described in breast cancer and following chemotherapy with up to 75% self-reporting and \~50% objectively demonstrating at least mild cognitive deficits after chemotherapy. Memantine, an N-methyl-D-aspartate receptor antagonist, is a promising medication to address underlying mechanisms of CRCI, including inflammation and pathways involving brain-derived neurotrophi…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: In order to participate in the study a subject must meet all of the eligibility criteria outlined below. * Female * Age ≥ 18 years at the time of consent. * Stage I-III Breast Cancer * Recommended chemotherapy * Enroll prior to 3rd cycle of chemotherapy * 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 * Seve…
Interventions
- DrugMemantine
memantine capsule
- DrugPlacebo medication
placebo capsule
- OtherExercise Intervention
Exercise Intervention participants will concurrently engage in remotely delivered Get Real \& Heel, 3d/week. Intensity for aerobic and strength-training components will progress as tolerated under the direction of a trained exercise physiologist.
- OtherExercise Control
Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.
Location
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel HillChapel Hill, North Carolina