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

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 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.

Conditions

• Breast Cancer
• Locally Advanced Breast Cancer
• Cognitive Impairment
• Cognitive Decline
• Cognitive Change
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Zev Nakamura, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-19

Primary Completion

2029-06-15

Completion

2029-06-15

FDA Drug

Yes

Countries

• United States

Study Locations