Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called memantine, combined with an exercise program called Get Real & Heel, can help improve thinking and memory skills in women with breast cancer who are undergoing chemotherapy. The study will involve 90 women with early to advanced stages of breast cancer who have noticed some mild memory problems. Participants will be divided into three groups: one group will receive memantine and do the exercise program, another group will take memantine only, and the last group will receive a placebo (a pill that looks like the medication but has no active ingredients). The researchers want to see how well the participants stick with the program, how they feel about it, and if their cognitive function improves over time.

To be eligible for the study, participants must be women aged 50 or older who have been diagnosed with stage I-III breast cancer and have already completed at least one cycle of chemotherapy. They should also have some mild memory concerns. However, women who have severe cognitive issues, certain heart problems, or who are very active with exercise may not qualify. If you join the study, you can expect to take part in assessments of your thinking skills and overall health at various times during the trial. This research could provide valuable insights into helping women maintain their cognitive abilities during cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• • Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. The subject is willing and able to comply with study procedures based on the judgment of the investigator.
• • Female
• • Age ≥ 50 years at the time of consent.
• • Stage I-III Breast Cancer
• • Completed at least 1 cycle of standard-of-care neoadjuvant or adjuvant chemotherapy
• • At least mild self-reported cognitive concerns ≥3 on a 0-10 scale
• • English-speaking
• Exclusion Criteria:
• • Allergy to memantine
• • Previous radiation, cancer-directed hormonal therapy, chemotherapy (prior to the current regimen), or immune checkpoint inhibitors
• • Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
• • \>30 min vigorous or \>60 min moderate physical activity per week
• • 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