NCT06727773RecruitingPhase 2
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 19 Aug 2025
- Primary completion date
- 15 Jun 2029
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06727773
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 19 Aug 2025 to the primary completion date, 15 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy (prior to the current regimen),
- Current alcohol or drug abuse
Other illness
- Allergy to memantine
- Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
- Myocardial infarction in the last 6 months
- Severe mental illness (i.e., schizophrenia or bipolar affective disorder)
Other
- Cardiovascular or orthopedic limitations to exercise
- Inability to swallow capsules \</= 5mL/min
- CrCl \</= 5mL/min
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.