Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitiv… (NCT06727773) | Clinical Trial Compass
RecruitingPhase 2
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
United States90 participantsStarted 2025-08-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
In order to participate in the study a subject must meet all of the eligibility criteria outlined below.
* Female
* Age ≥ 18 years at the time of consent.
* Stage I-III Breast Cancer
* Recommended chemotherapy
* Enroll prior to 3rd cycle of chemotherapy
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of recruitment
Timeframe: Baseline
2
Rates of retention
Timeframe: Up to a year
3
Rates of adherence
Timeframe: Up to a year
4
The acceptability of memantine + Get Real and Heel (MEM+EX)