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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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 with mild cognitive difficulties 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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⁃ In order to participate in the study a subject must meet all of the eligibility criteria outlined below.

• Female

• Age ≥ 50 years at the time of consent.

• Stage I-III Breast Cancer

• Recommended chemotherapy

• Enroll prior to 3rd cycle of chemotherapy

• Completed at least 1 cycle of standard-of-care neoadjuvant or adjuvant chemotherapy

• At least mild self-reported cognitive concerns ≥3 on a 0-10 scale

• English-speaking

Locations
United States
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Ashley M Hanson
Ashley_Hanson@med.unc.edu
+1 984-888-9244
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov