RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether memantine, with or without an exercise program, may help memory and thinking during chemotherapy. It is for women with stage I–III breast cancer. Participants are placed by chance into one of three groups: memantine plus exercise, memantine alone, or a placebo (a pill with no active medicine).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and age 18 or older when agreeing to join.
  • Have stage I–III breast cancer.
  • Have chemotherapy recommended.
  • Join before the third cycle of chemotherapy.
  • Speak English.

Who can't join

  • Are allergic to memantine.
  • Had chemotherapy before the current treatment plan.
  • Have severe memory or thinking problems, with a score of 11 or higher on the study’s memory and thinking test.
  • Had a heart attack in the past 6 months, or have heart, bone, or joint problems that limit exercise.
  • Have a severe mental illness, such as schizophrenia or bipolar disorder.
  • Currently abuse alcohol or drugs.
  • Cannot swallow capsules.
  • Have creatinine clearance (a measure of how well the kidneys filter blood) of 5 mL/min or less.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

NC