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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Oct 31, 2028 to Jun 15, 2029
    • Start date: May 7, 2025 to Aug 19, 2025
    • Eligibility criteria shortened, about 22 words
    v10
  2. Eligibility criteria shortened, about 48 wordsv9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 20, 2025 to May 7, 2025
    • Site details revised
    v8
  4. Trial status: Recruiting to Not Yet Recruiting
    • Start date: May 7, 2025 to May 20, 2025
    • Site details revised
    v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to May 7, 2025
    • Site details revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 2025 to Jun 2025v5
  2. Interventions: Exercise Control (Other), Exercise Intervention (Other), Memantine (Drug), Placebo (Drug) to Exercise Control (Other), Exercise Intervention (Other), Memantine (Drug), Placebo medication (Drug)v4
  3. Secondary endpoints: details revised at 3 of 5 entriesv3
  4. Start date: Dec 2024 to Mar 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06727773
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Breast Cancer, Locally Advanced Breast Cancer, Cognitive Impairment, Cognitive Decline, Cognitive Change, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Related terms Breast Neoplasms, Cognitive Dysfunction, Motor Activity
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov