Memantine for the Improvement of Cognitive Function in Breast Cancer Patients Receiving Chemotherapy

PRIMARY OBJECTIVE:

I. To estimate the impact of memantine hydrochloride (memantine) on putative biomarkers of cancer-related cognitive impairment (CRCI) during breast cancer chemotherapy.

SECONDARY OBJECTIVE:

I. To determine the association between changes in CRCI biomarkers and cognitive function.

EXPLORATORY OBJECTIVES:

I. To explore the preliminary efficacy of memantine for CRCI.

II. To explore if memantine-related improvements in cognitive function are mediated by changes in BDNF and inflammation.

III. To explore if memantine-related improvements in cognitive function are moderated by baseline physical activity.

IV. To compare adverse events between memantine and placebo arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive memantine beginning between cycles 2 and 3 of standard of care (SOC) chemotherapy. Patients receive memantine orally (PO) once daily (QD) during week 1 and twice daily (BID) from week 2 onward. Treatment repeats until 1 month after last dose of SOC chemotherapy, approximately 8-26 weeks, in the absence of unacceptable toxicity.

ARM 2: Patients receive placebo beginning between cycles 2 and 3 of SOC chemotherapy. Patients receive placebo PO QD during week 1 and BID from week 2 onward. Treatment repeats until 1 month after last dose of SOC chemotherapy, approximately 8-26 weeks, in the absence of unacceptable toxicity.

Additionally, patients wear an accelerometer to track physical activity and sleep over 7 consecutive days and undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at 4 weeks after SOC chemotherapy cycle and at 6 months after the last dose of study drug.