Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Recruiting · NCT06727773 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- Severe mental illness (i.e., schizophrenia or bipolar affective disorder)
- Current alcohol or drug abuse
- Inability to swallow capsules \</= 5mL/min
- CrCl \</= 5mL/min
Where it is running
1 location listed across 1 US state.
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill - Chapel Hill, North Carolina, United States