Memantine plus structured exercise to protect thinking and memory during breast cancer chemotherapy
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
This will test whether memantine combined with a supervised exercise program, memantine alone, or a placebo can prevent or reduce thinking and memory problems in people receiving chemotherapy for stage I–III breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06727773 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 2 trial will enroll 90 women with stage I–III breast cancer who begin chemotherapy and randomize them to memantine plus the UNC Get Real & Heel exercise program, memantine alone, or placebo. The study focuses on feasibility and acceptability of the combined intervention and collects preliminary efficacy data on cognitive performance. Blood biomarkers including brain-derived neurotrophic factor (BDNF) and inflammatory markers, along with frailty measures, will be measured at multiple time points. Outcomes will inform whether the combined approach affects biomarkers and cognitive trajectories during chemotherapy.
Who should consider this trial
Good fit: Women aged 18 or older with stage I–III breast cancer who are English-speaking, recommended for chemotherapy, and can enroll before their third chemotherapy cycle are the intended participants.
Not a fit: Patients with severe cognitive impairment, significant cardiac or orthopedic limitations to exercise, allergy to memantine, recent prior chemotherapy, or severe psychiatric or substance-use disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could help prevent or lessen chemotherapy-related thinking and memory problems and identify biological markers to guide future treatments.
How similar studies have performed: Exercise and memantine have each shown promise for cognitive outcomes in related settings, but combining memantine with a supervised cancer-specific exercise program for chemotherapy-related cognitive decline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Zev Nakamura, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Ashley M Hanson
- Email: Ashley_Hanson@med.unc.edu
- Phone: +1 984-888-9244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.