Clinical trial · Interventional
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Cognitive Change | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Control | Other | — | UNRESOLVED |
| Exercise Intervention | Other | — | UNRESOLVED |
| Memantine | Drug | — | UNRESOLVED |
| Placebo medication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist.
- interventionNames
- Drug: Memantine
- Other: Exercise Intervention
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Participants have access to a library of pre-recorded Get Real \& Heel sessions.
- interventionNames
- Drug: Placebo medication
- Other: Exercise Control
- type
- EXPERIMENTAL
- label
- Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available