RecruitingPhase 2NCT06727773

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


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

90 participants

Start Date

May 7, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called memantine (commonly used for Alzheimer's) combined with an exercise program can protect and improve thinking and memory in women with breast cancer who are experiencing cognitive side effects from chemotherapy (sometimes called "chemo brain"). **You may be eligible if...** - You are a woman aged 50 or older - You have stage I-III breast cancer and are recommended to receive chemotherapy - You have had at least one cycle of standard chemotherapy and have not yet started your 3rd cycle - You are experiencing at least mild cognitive concerns (rated at least 3 out of 10) - You speak English **You may NOT be eligible if...** - You are allergic to memantine - You received chemotherapy before your current treatment - You have severe cognitive impairment - You had a heart attack within the last 6 months - You have heart or joint problems that prevent safe exercise - You have severe mental illness, active substance abuse, or cannot swallow capsules - You have significantly reduced kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

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NCT06727773


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