Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer

NCT ID: NCT04033419

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2022-04-04

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 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.

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 participants referred to the University of North Carolina (UNC) Breast Center and affiliated outpatient clinics for initiation of adjuvant or neoadjuvant chemotherapy, perform a cognitive assessment within one week of initiating and four weeks after completion of chemotherapy, and treat with memantine 10 mg twice daily between the pre- and post-chemotherapy study assessments (estimated duration: 12-26 weeks, depending on the chemotherapy regimen). Cognitive function will be assessed objectively using a computerized cognitive assessment (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 are comorbidities known to affect cognitive function, and therefore will be assessed as covariates pre- and post-chemotherapy. Depression, anxiety, health-related quality of life (HRQOL) and functional status will be evaluated as secondary outcomes. The feasibility of the investigator's study by monitoring recruitment, retention, and adherence to memantine will be assessed.

Conditions

Cognitive Decline; Chemo-brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Memantine

Subjects receive memantin

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

memantine dose

• Week 1: 5 mg dose once daily
• Week 2: 5 mg dose twice daily
• Week 3: 5 mg each morning/10 mg each evening
• Week 4 through the end of Chemotherapy: 10 mg dose twice daily
• Total duration: 12 - 26 weeks (depending on chemotherapy regimen)

Interventions

Memantine

memantine dose

• Week 1: 5 mg dose once daily
• Week 2: 5 mg dose twice daily
• Week 3: 5 mg each morning/10 mg each evening
• Week 4 through the end of Chemotherapy: 10 mg dose twice daily
• Total duration: 12 - 26 weeks (depending on chemotherapy regimen)

Intervention Type: DRUG

Other Intervention Names

Namenda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zev M Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Univesity of North Carolina at Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Nakamura ZM, Deal AM, Park EM, Stanton KE, Lopez YE, Quillen LJ, O'Hare Kelly E, Heiling HM, Nyrop KA, Ray EM, Dees EC, Reeder-Hayes KE, Jolly TA, Carey LA, Abdou Y, Olajide OA, Rauch JK, Joseph R, Copeland A, McNamara MA, Ahles TA, Muss HB. A phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects. Cancer Med. 2023 Apr;12(7):8172-8183. doi: 10.1002/cam4.5619. Epub 2023 Jan 16.

Reference Type: DERIVED

PMID: 36645168 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5K12HD001441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC1921

Identifier Type: -

Identifier Source: org_study_id