This phase II trial studies whether memantine, a medication commonly used for dementia, may lessen chemotherapy-related cognitive changes, also known as ''chemobrain,'' experienced by some patients receiving treatment for breast cancer. Cancer-related cognitive change refers to memory and concentration problems that can occur with cancer and cancer treatments. Memantine blocks the uptake of calcium by certain brain cells and decreases abnormal activity in the brain. Giving memantine may prevent chemotherapy-related cognitive decline, improve quality of life, physical function, and mental health in patients with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04033419.
PRIMARY OBJECTIVE:
I. To compare changes in pre- to post-chemotherapy cognitive function, as measured by Delayed Matching to Sample Test (DMS) score, in our cohort of patients with breast cancer receiving memantine hydrochloride (memantine) to historical controls.
SECONDARY OBJECTIVES
I. To compare pre- to post-chemotherapy changes in all other objective and self-reported cognitive function measures.
II. To examine associations between objective and self-reported cognitive function with depression, anxiety, fatigue, menopausal status, baseline intelligence quotient (IQ), and perceived cognitive effort, cross-sectionally pre- and post-chemotherapy.
III. To explore the impact of cognitive decline on health-related quality of life (HRQOL), functional status, depression, and anxiety.
IV. To estimate the feasibility of conducting a clinical trial of memantine for attenuating cognitive decline in patients with breast cancer during chemotherapy.
V. To describe the safety of administering memantine to patients with breast cancer during chemotherapy.
EXPLORATORY OBJECTIVES:
I. To compare pre- to 6 months post-chemotherapy changes in objective and self-reported cognitive function measures.
II. To describe changes in depression, anxiety, fatigue, HRQOL, and functional status from pre- to 6 months post-chemotherapy.
OUTLINE: Beginning within 4 weeks prior to the start of chemotherapy and 1 week after chemotherapy initiation, patients receive memantine orally (PO) once daily (QD) in week 1, PO twice daily (BID) in weeks 2-4 for up to 4 weeks post-chemotherapy. At baseline and post-chemotherapy, patients also complete a cognitive assessment over 70 minutes.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorZev Nakamura
