Status:
COMPLETED
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cognitive Decline
Chemo-brain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 contro...
Detailed Description
This is a one-arm phase II interventional study in patients with breast cancer to investigate whether memantine can prevent cognitive decline during chemotherapy. The investigators will recruit 56 par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04033419
Start Date
September 25 2019
End Date
April 4 2022
Last Update
April 20 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514