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

Description

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.

Conditions

Breast CancerLocally Advanced Breast CancerCognitive ImpairmentCognitive DeclineCognitive ChangeBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III
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Related Conditions:

Breast CancerLocally Advanced Breast CancerCognitive ImpairmentCognitive DeclineCognitive ChangeBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III

Study Overview

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Study Details

Study 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 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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. The subject is willing and able to comply with study procedures based on the judgment of the investigator.
  • * Female
  • * Age ≥ 50 years at the time of consent.
  • * Stage I-III Breast Cancer
  • * 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
  • * Allergy to memantine
  • * Previous radiation, cancer-directed hormonal therapy, chemotherapy (prior to the current regimen), or immune checkpoint inhibitors
  • * Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
  • * \>30 min vigorous or \>60 min moderate physical activity per week
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

Zev Nakamura, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

2028-10-31