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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to MEM+EX (memantine + exercise), memantine, or placebo using a computer-generated randomization scheme that stratifies for an equal balance of age. All study personnel and participants will remain blinded until data collection is complete.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist.

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

memantine capsule

Exercise Intervention

Intervention Type OTHER

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.

Arm 2

Participants have access to a library of pre-recorded Get Real \& Heel sessions.

Group Type PLACEBO_COMPARATOR

Placebo medication

Intervention Type DRUG

placebo capsule

Exercise Control

Intervention Type OTHER

Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Arm 3

Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real \& Heel sessions.

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

memantine capsule

Exercise Control

Intervention Type OTHER

Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Interventions

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Memantine

memantine capsule

Intervention Type DRUG

Placebo medication

placebo capsule

Intervention Type DRUG

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.

Intervention Type OTHER

Exercise Control

Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Intervention Type OTHER

Other Intervention Names

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Get Real & Heel Exercise library

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No