Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06727773
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Cognitive Change
  • Cognitive Decline
  • Cognitive Impairment
  • Locally Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Memantine — DRUG
    memantine capsule
  • Placebo medication — DRUG
    placebo capsule
  • Exercise Intervention — OTHER
    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 — OTHER
    Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Study Details

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.

Key Dates

Start date
Aug 19, 2025
Status verified
May 2026
Primary completion
Jun 15, 2029
Completion
Jun 15, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Rates of recruitment [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel HillChapel HillNorth Carolina27599
Zev M Nakamura, MD
[email protected]
Zev M Nakamura, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill· Chapel Hill, NC

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