Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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)
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Able to provide informed consent

• At least 18 years of age

• Able to speak English

• Diagnosed with breast cancer, Stages I-III

• Scheduled for adjuvant or neoadjuvant chemotherapy

Exclusion Criteria:

• A history of adverse reaction to memantine

• Another cancer diagnosis with an estimated survival of less than five years

• Previous chemotherapy exposure

• Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test (BOMC) ≥ 11.

• Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment, or breastfeeding

• Current alcohol or drug abuse