Actively Recruiting
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-05-06
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating memantine combined with the University of Carolina's Get Real & Heel cancer exercise program (MEM+EX) to address cognitive impairment related to breast cancer and its treatment. This randomized, placebo-controlled phase 2 trial focuses on women with stage I to III breast cancer undergoing chemotherapy, aiming to assess the feasibility, acceptability, and early effects of these interventions on cognitive function and biological markers like brain-derived neurotrophic factor (BDNF) and inflammation. Participants will be randomly assigned to one of three groups: MEM+EX (memantine plus guided exercise sessions), memantine alone with access to pre-recorded exercise sessions, or placebo with access to pre-recorded exercise sessions. Exercise sessions include aerobic and strength training delivered remotely three times per week under supervision. The trial evaluates recruitment, retention, adherence, and acceptability during chemotherapy and up to one year of follow-up. During the study, participants undergo assessments of cognitive function, patient-reported cognition, biomarker levels related to cognitive decline, and frailty at baseline and throughout the year. Researchers closely monitor adherence to medications and exercise, retention rates, and the overall acceptability of the interventions. This study aims to provide important data for future trials targeting cognitive decline in breast cancer patients receiving chemotherapy.
CONDITIONS
Brief Title
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 years or older at the time of consent
- Diagnosed with stage I to III breast cancer
- Recommended to undergo chemotherapy
- Enrollment before the third cycle of chemotherapy
- English-speaking
You will not qualify if you...
- Allergy to memantine
- Previous chemotherapy before the current regimen
- Severe cognitive impairment (Blessed Orientation Memory Concentration Test Score ≥11)
- Heart attack within the last 6 months
- Cardiovascular or orthopedic problems limiting exercise
- Severe mental illness such as schizophrenia or bipolar disorder
- Current alcohol or drug abuse
- Inability to swallow capsules
- Creatinine clearance ≤5 mL/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive study medication (memantine or placebo) and engage in exercise interventions or access exercise resources during chemotherapy.
Weekly visits during chemotherapy
Duration - Up to 1 year
Participants are followed to assess cognitive function, biomarkers, and acceptability of the interventions after treatment.
Periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
A
Ashley M Hanson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here