Recruiting
Phase 2

MEM+EX

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06727773

Conditions

Breast Cancer

Locally Advanced Breast Cancer

Cognitive Impairment

Cognitive Decline

Cognitive Change

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Memantine

Placebo medication

Exercise Intervention

Exercise Control

Study Details

Brief summary:

This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.

Conditions

Breast Cancer

Locally Advanced Breast Cancer

Cognitive Impairment

Cognitive Decline

Cognitive Change

Study ID

NCT06727773

Start date

Aug 19, 2025

Status verified date

May, 2026

Completion date

Jun 15, 2029

Anticipated

Primary completion date

Jun 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

In order to participate in the study a subject must meet all of the eligibility criteria outlined below.

  • Female
  • Age ≥ 18 years at the time of consent.
  • Stage I-III Breast Cancer
  • Recommended chemotherapy
  • Enroll prior to 3rd cycle of chemotherapy
  • English-speaking

Exclusion Criteria:

  • Allergy to memantine
  • Previous chemotherapy (prior to the current regimen),
  • Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
  • Myocardial infarction in the last 6 months
  • Cardiovascular or orthopedic limitations to exercise
  • Severe mental illness (i.e., schizophrenia or bipolar affective disorder)
  • Current alcohol or drug abuse
  • Inability to swallow capsules </= 5mL/min
  • CrCl </= 5mL/min

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1

Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist.

placebo comparator: Arm 2

Participants have access to a library of pre-recorded Get Real \& Heel sessions.

experimental: Arm 3

Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real \& Heel sessions.

Interventions

Memantine

memantine capsule

Placebo medication

placebo capsule

Exercise Intervention

Exercise Intervention participants will concurrently engage in remotely delivered Get Real \& Heel, 3d/week. Intensity for aerobic and strength-training components will progress as tolerated under the direction of a trained exercise physiologist.

Exercise Control

Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Primary outcome measure

  • Rates of recruitment [ Time Frame: Baseline ]
  • Rates of retention [ Time Frame: Up to a year ]
  • Rates of adherence [ Time Frame: Up to a year ]
  • The acceptability of memantine + Get Real and Heel (MEM+EX) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Ashley M Hanson

+1 984-888-9244Ashley_Hanson@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Zev M Nakamura, MD

zev_nakamura@med.unc.edu

Principal Investigator:

Zev M Nakamura, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • chemotherapy
  • memantine
  • placebo-controlled
  • exercise
  • Get Real & Heel cancer exercise program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-05-06.