NCT06727773 Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
| NCT ID | NCT06727773 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2029-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-08-19 with a primary completion date of 2029-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Zev Nakamura, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06727773 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06727773 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06727773 currently recruiting?
Yes, NCT06727773 is actively recruiting participants. Contact the research team at Ashley_Hanson@med.unc.edu for enrollment information.
Where is the NCT06727773 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06727773 clinical trial?
NCT06727773 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Zev Nakamura, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 90 participants.
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