Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Memantine, Placebo medication, Exercise Intervention, Exercise Control.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Locally Advanced Breast Cancer, Cognitive Impairment, Cognitive Decline. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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 neurotrophic factor (BDNF). Exercise, a promising intervention for frailty which intervenes on multiple mechanisms of aging, is an ideal strategy to augment the targeted effects of memantine.
The primary objective of this study is to demonstrate the feasibility and acceptability of MEM+EX during breast cancer chemotherapy. Secondarily, the preliminary efficacy of MEM+EX and memantine on putative biomarkers of CRCI and cognitive function will be evaluated. Furthermore, the impact of frailty on the preliminary efficacy of MEM+EX and memantine will be explored.
The proposed study has the potential to produce significant public health benefit by filling a major gap in effective CRCI treatments. It will provide important pilot data for future, definitive randomized controlled studies. Finally, this study will advance understanding of potential targets to pursue in future cognitive interventions, including pathways involving BDNF and inflammation, during treatment for cancer.
Interventions
- Drug Memantine
memantine capsule - Drug Placebo medication
placebo capsule - Other Exercise 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. - Other Exercise Control
Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.
Primary outcome measures
- Rates of recruitment [Time frame: Baseline]
- Rates of retention [Time frame: Up to a year]
- Rates of adherence [Time frame: Up to a year]
- The acceptability of memantine + Get Real and Heel (MEM+EX) [Time frame: Up to 6 months]
Secondary outcome measures (5)
- Attention and Executive Function Composite Score [Time frame: Baseline and up to 1 year]
- Learning and Memory Composite Score [Time frame: Baseline and up to 1 year]
- Changes in patient-reported cognition [Time frame: Baseline and up to 1 year]
- The impact of MEM+EX and memantine on brain-derived neurotrophic factor (BDNF) [Time frame: Baseline and up to 6 months]
- The impact of MEM+EX and memantine on inflammatory markers [Time frame: Baseline and up to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06727773 · LCCC2425 · K23AG086604