Memantine and Exercise for Cognitive Issues in Breast Cancer
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Recruiting
Phase 2Interventional Study
Breast CancerLocally Advanced Breast CancerCognitive ImpairmentCognitive DeclineCognitive ChangeBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
90 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for women with stage I-III breast cancer who are receiving chemotherapy. Participants will take memantine or a placebo, and also take part in an exercise program to see if it helps improve thinking skills during treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am female
I am 18 years or older
I have stage I-III breast cancer
I am recommended to start chemotherapy
I can enroll before my 3rd chemotherapy cycle
I speak English
You may not be able to join if
I am allergic to memantine
I have had chemotherapy before this treatment
I have severe cognitive impairment
I have had a heart attack in the last 6 months
I have limitations that prevent me from exercising
I have severe mental illness
I currently abuse alcohol or drugs
I cannot swallow capsules
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 gro…
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.
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Eligibility Criteria
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
Excl…
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
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