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Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer

RECRUITINGPhase 2Sponsored by UNC Lineberger Comprehensive Cancer Center
Actively Recruiting
PhasePhase 2
SponsorUNC Lineberger Comprehensive Cancer Center
Started2025-05-07
Est. completion2028-10-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Breast CancerBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIICancerCognitive ChangeCognitive DeclineCognitive ImpairmentLocally Advanced Breast Cancer

Locations1 site

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Zev M Nakamura, MDzev_nakamura@med.unc.edu

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