Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Status:
Active, not recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to
post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving
memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline
Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported
cognitive function; and (3) estimate the feasibility of conducting a clinical trial of
memantine for attenuating cognitive decline in patients with breast cancer during
chemotherapy.
Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or
neoadjuvant chemotherapy.
Procedures (methods): Cognitive assessments will be performed within one week of initiating
and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice
daily between the pre- and post-chemotherapy study assessments. Cognitive function will be
assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS)
test) and a standard neuropsychological battery. To assess subjective cognitive function, the
Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure
will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as
covariates.
Phase:
Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center University of North Carolina, Chapel Hill
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)