Phase 2
N=51
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Cognitive Decline · Chemo-brain
Bottom Line
View on ClinicalTrials.gov: NCT04033419 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Visual Working Memory - Delayed Matching to Sample Test — 16; 13; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Memantine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Working Memory - Delayed Matching to Sample Test |
16; 13; 16 | — |
| SECONDARY Change in Verbal Memory - Hopkins Verbal Learning Test-Revised |
22; 16; 7 | — |
| SECONDARY Change in Processing Speed and Executive Function - Trail Making Test |
27.58; 79.42; 32.65; 87.53 | — |
| SECONDARY Change in Processing Speed - Rapid Visual Processing (RVP) |
10; 17; 4 | — |
| SECONDARY Change in Executive Function - One Touch Stockings (OTS) of Cambridge |
9; 16; 6 | — |
| SECONDARY Change in Attention and Working Memory - Digit Span |
7; 31; 7 | — |
| SECONDARY Change in Verbal Fluency - Controlled Oral Word Association Test |
18; 18; 9 | — |
| SECONDARY Change in Semantic Fluency - Animal Naming Test |
10; 16; 19 | — |
| SECONDARY Change in Self-reported Cognitive Function - PROMIS Cognitive Function |
18; 2; 1; 14; 8; 0 | — |
| SECONDARY Change in Depressive Symptoms - PROMIS Depression |
50; 43; 1; 1 | — |
| SECONDARY Change in Anxiety Symptoms - PROMIS Emotional Distress-Anxiety |
48; 40; 3; 5 | — |
| SECONDARY Change in Karnofsky Performance Status |
37; 5; 39; 3 | — |
| SECONDARY Change in Quality of Life - Functional Assessment of Cancer Therapy-General |
83.7; 82.6 | — |
| SECONDARY Proportion of Invited Participants Who Enroll - Recruitment |
412; 55; 4; 51 | — |
| SECONDARY Proportion of Enrolled Participants Who do Not Meet the Primary Outcome Measure - Attrition |
45; 3; 3 | — |
| SECONDARY Proportion of Scheduled Drug Doses Taken - Adherence |
4; 39; 12 | — |
| SECONDARY Number of Adverse Events - Safety |
19; 16; 12; 12; 10; 4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04033419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.