Trial Radar KI | ||
|---|---|---|
enums.trial_summary.trial_summary_welcome | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06727773 untersucht Supportivtherapie im Zusammenhang mit Brustkrebs, Lokal Fortgeschrittener Brustkrebs, Kognitive Beeinträchtigung, Kognitiver Abbau, Kognitive Veränderung, Brustkrebsstadium I, Brustkrebs Stadium II, Brustkrebs Stadium III. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 7. Mai 2025. Es ist geplant, 90 Teilnehmer aufzunehmen. Durchgeführt von UNC Lineberger Comprehensive Cancer Center wird der Abschluss für 31. Oktober 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 2. September 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
There are 4 million breast cancer survivors in the U.S. and an estimated 1.4 million suffer from long-term cognitive deficits from cancer treatment. Compared to other cancers and treatments, cognitive decline has been most robustly described in breast cancer and following chemotherapy with up to 75% self-reporting and ~50% objectively demonstrating at least mild cognitive deficits after chemotherapy. Memantine, an N-methyl-D-aspartate receptor antagonist, is a promising medication to address underlying mechanisms of CRCI, including inflammation and pathways involving brain-derived neurotrophic factor (BDNF). Exercise, a promising intervention for frailty which intervenes on multiple mechanisms of aging, is an ideal strategy to augment the targeted effects of memantine.
The primary objective of this study is to demonstrate the feasibility and acceptability of MEM+EX during breast cancer chemotherapy. Secondarily, the preliminary efficacy of MEM+EX and memantine on putative biomarkers of CRCI and cognitive function will be evaluated. Furthermore, the impact of frailty on the preliminary efficacy of MEM+EX and memantine will be explored.
The proposed study has the potential to produce significant public health benefit by filling a major gap in effective CRCI treatments. It will provide important pilot data for future, definitive randomized controlled studies. Finally, this study will advance understanding of potential targets to pursue in future cognitive interventions, including pathways involving BDNF and inflammation, during treatment for cancer.
Offizieller Titel
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Erkrankungen
BrustkrebsLokal Fortgeschrittener BrustkrebsKognitive BeeinträchtigungKognitiver AbbauKognitive VeränderungBrustkrebsstadium IBrustkrebs Stadium IIBrustkrebs Stadium IIIWeitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2025-05-07
Zuletzt aktualisiert
2025-09-02
Studienende (vorauss.)
2028-10-31
Geplante Rekrutierung
90
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
chemotherapy
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellArm 1 Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist. | Memantine memantine capsule Bewegungsintervention Exercise Intervention participants will concurrently engage in remotely delivered Get Real \& Heel, 3d/week. Intensity for aerobic and strength-training components will progress as tolerated under the direction of a trained exercise physiologist. |
Placebo-VergleichspräparatArm 2 Participants have access to a library of pre-recorded Get Real \& Heel sessions. | Placebo Medication placebo capsule Exercise Control Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions. |
ExperimentellArm 3 Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real \& Heel sessions. | Memantine memantine capsule Exercise Control Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Rates of recruitment | Rates of recruitment will be measured as a number of subjects joined the study. | Baseline |
Rates of retention | Rates of retention will be measured as the proportion of subjects who remained in the study at post-intervention (up to 6 months) and after 6 months among those who started the intervention | Up to a year |
Rates of adherence | Rates of adherence will be measured as a number of subjects who joined the study completed 80 percent of planned study activities. | Up to a year |
The acceptability of memantine + Get Real and Heel (MEM+EX) | The acceptability of memantine + Get Real and Heel (MEM+EX) will be assessed using the Client Satisfaction Questionnaire (CSQ-3). CSQ-3 is a three-item measure of treatment acceptability that has demonstrated excellent reliability and validity across a range of patient care settings.
Each item is scored on a Likert-type scale from 1 (low satisfaction) to 4 (high satisfaction). CSQ-3 will be completed at post-intervention only (or at the time of withdrawal from the study, if applicable). | Up to 6 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Attention and Executive Function Composite Score | The attention and executive function score is a composite of the following neuropsychological assessment measures: Digit Span, Trail Making Test Parts A\&B, Controlled Oral Word Association Test, and Animal Naming Test. It will be calculated as the sum of Z-scores (standardized based on available age-, sex-, education-, and race/ethnicity-matched normative data) of the individual subtests and range from a Z-score of -3 to +3. | Baseline and up to 1 year |
Learning and Memory Composite Score | The learning and memory score is a composite of the following neuropsychological assessment measures: Hopkins Verbal Learning Test-Revised and Brief Visual Memory Test-Revised. It will be calculated as the sum of Z-scores (standardized based on available age-, sex-, education-, and race/ethnicity-matched normative data) of the individual subtests and range from a Z-score of -3 to +3. | Baseline and up to 1 year |
Changes in patient-reported cognition | The impact of MEM+EX and memantine on cognitive function will be determined by examining changes in patient-reported cognition, as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog PCI) version 3, compared to placebo.
FACT-Cog PCI is a self-report measure designed to assess perceived cognitive functioning in cancer patients, particularly those experiencing chemotherapy-induced cognitive problems. It consists of 18 items and each item is rated on a 5-point Likert scale, ranging from 0 (Never) to 4 (Several times a day). The total score is obtained by summing the subscale scores. Higher scores indicate better perceived cognitive functioning. | Baseline and up to 1 year |
The impact of MEM+EX and memantine on brain-derived neurotrophic factor (BDNF) | The impact of MEM+EX and memantine on putative biomarkers of CRCI will be determined by examining changes in BDNF compared to placebo. | Baseline and up to 6 months |
The impact of MEM+EX and memantine on inflammatory markers | The impact of MEM+EX and memantine on putative biomarkers of CRCI will be determined by examining changes in inflammatory composite measure (TNF-alpha, IL-6, CRP) compared to placebo. | Baseline and up to 6 months |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
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
- 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
UNC Lineberger Comprehensive Cancer CenterNational Institute on Aging (NIA)Zentrale Studienkontakte
Kontakt: Ashley M Hanson, +1 984-888-9244, [email protected]
1 Studienstandorte in 1 Ländern
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States
Zev M Nakamura, MD, Kontakt, [email protected]
Zev M Nakamura, MD, Hauptprüfer
Offene Rekrutierung