Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
UNC Lineberger Comprehensive Cancer Center
90 participants
May 7, 2025
INTERVENTIONAL
Conditions
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 Criteria9
- 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 Criteria9
- 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
Interventions
memantine capsule
placebo capsule
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.
Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06727773