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NCT04033419 · ClinicalTrials.gov registry record · Phase 2
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT04033419 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 55 participants.
The verdict
NCT04033419, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study 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.
Interventions
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04033419
The ClinicalTrials.gov registry entry for NCT04033419 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Memantine is the first listed.
NCT04033419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04033419 about?
NCT04033419 is a clinical study titled "Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer". 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...
What is the current status of trial NCT04033419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2019-09-25. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT04033419?
The interventions under investigation include: Memantine (DRUG).
Who is sponsoring clinical trial NCT04033419?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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