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Идёт набор NCT06727773

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

Фаза II С лечением Breast Cancer Locally Advanced Breast Cancer Cognitive Impairment Cognitive Decline

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Memantine, Placebo medication, Exercise Intervention, Exercise Control.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Locally Advanced Breast Cancer, Cognitive Impairment, Cognitive Decline. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Memantine
    memantine capsule
  • Препарат Placebo medication
    placebo capsule
  • Другое Exercise Intervention
    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.
  • Другое Exercise Control
    Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions.

Первичные конечные точки

  • Rates of recruitment [Срок оценки: Baseline]
  • Rates of retention [Срок оценки: Up to a year]
  • Rates of adherence [Срок оценки: Up to a year]
  • The acceptability of memantine + Get Real and Heel (MEM+EX) [Срок оценки: Up to 6 months]
Вторичные конечные точки (5)
  • Attention and Executive Function Composite Score [Срок оценки: Baseline and up to 1 year]
  • Learning and Memory Composite Score [Срок оценки: Baseline and up to 1 year]
  • Changes in patient-reported cognition [Срок оценки: Baseline and up to 1 year]
  • The impact of MEM+EX and memantine on brain-derived neurotrophic factor (BDNF) [Срок оценки: Baseline and up to 6 months]
  • The impact of MEM+EX and memantine on inflammatory markers [Срок оценки: Baseline and up to 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06727773 · LCCC2425 · K23AG086604

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗