RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2025-05-07
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06727773

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Female
  3. * Age ≥ 50 years at the time of consent.
  4. * Stage I-III Breast Cancer
  5. * Completed at least 1 cycle of standard-of-care neoadjuvant or adjuvant chemotherapy
  6. * At least mild self-reported cognitive concerns ≥3 on a 0-10 scale
  7. * English-speaking
  1. * Allergy to memantine
  2. * Previous radiation, cancer-directed hormonal therapy, chemotherapy (prior to the current regimen), or immune checkpoint inhibitors
  3. * Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
  4. * \>30 min vigorous or \>60 min moderate physical activity per week
  5. * Myocardial infarction in the last 6 months
  6. * Cardiovascular or orthopedic limitations to exercise
  7. * Severe mental illness (i.e., schizophrenia or bipolar affective disorder) Current alcohol or drug abuse
  8. * Inability to swallow capsules \</= 5mL/min
  9. * CrCl \</= 5mL/min

Contacts and Locations

Study Contact

Ashley M Hanson
CONTACT
+1 984-888-9244
Ashley_Hanson@med.unc.edu

Principal Investigator

Zev Nakamura, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2025-05-07
Study Completion Date2028-10-31

Terms related to this study

Keywords Provided by Researchers

  • chemotherapy
  • memantine
  • placebo-controlled
  • exercise
  • Get Real & Heel cancer exercise program

Additional Relevant MeSH Terms

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