Memantine plus structured exercise to protect thinking and memory during breast cancer chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.