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O estudo clínico NCT06727773 para Câncer de mama, Câncer de Mama Localmente Avançado, Comprometimento cognitivo, Declínio cognitivo, Mudança cognitiva, Estágio I do câncer de mama, Câncer de mama estágio II, Câncer de mama estágio III está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06727773 procura avaliar cuidados de suporte para Câncer de mama, Câncer de Mama Localmente Avançado, Comprometimento cognitivo, Declínio cognitivo, Mudança cognitiva, Estágio I do câncer de mama, Câncer de mama estágio II, Câncer de mama estágio III. Este é um ensaio intervencionista de Fase II. Seu status atual é: recrutando. O estudo começou em 7 de maio de 2025 e pretende incluir 90 participantes. Coordenado por UNC Lineberger Comprehensive Cancer Center e deve ser concluído em 31 de outubro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de setembro de 2025.
Resumo
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.
Descrição detalhada
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.
Título oficial
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
Condições
Câncer de mamaCâncer de Mama Localmente AvançadoComprometimento cognitivoDeclínio cognitivoMudança cognitivaEstágio I do câncer de mamaCâncer de mama estágio IICâncer de mama estágio IIIOutros IDs do estudo
Número NCT
Data de início (real)
2025-05-07
Última atualização postada
2025-09-02
Data de conclusão (estimada)
2028-10-31
Inscrição (estimada)
90
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Recrutando
Palavras-chave
chemotherapy
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
Propósito principal
Cuidados de suporte
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalArm 1 Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist. | Memantine memantine capsule Intervenção de exercício 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. |
Comparador placeboArm 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. |
ExperimentalArm 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Feminino
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)Contato central do estudo
Contato: Ashley M Hanson, +1 984-888-9244, [email protected]
1 Locais do estudo em 1 países
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States
Zev M Nakamura, MD, Contato, [email protected]
Zev M Nakamura, MD, Investigador principal
Recrutando