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Идёт набор NCT05710809

The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Без фазы С лечением Colorectal Cancer Oncologic Complications Comprehensive Geriatric Assessment Vestibular Rehabilitation

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: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Oncologic Complications, Comprehensive Geriatric Assessment, Vestibular Rehabilitation. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Подробное описание

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

Вмешательства

  • Другое Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
    Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Первичные конечные точки

  • Dynamic Gait Index (DGI) [Срок оценки: Three months]
  • 30 second Sit-to-Stand Test (30STS) [Срок оценки: Three months]
Вторичные конечные точки (11)
  • Falls [Срок оценки: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks]
  • Hospital contacts due to falls [Срок оценки: Baseline, three and six months]
  • Balance disabilities/dizziness [Срок оценки: Baseline, three and six months]
  • Fear of falling [Срок оценки: Baseline, three and six months]
  • Health related quality of life [Срок оценки: Baseline, three and six months]
  • Peripheral nerve function [Срок оценки: Baseline, three and six months]
  • Autonomic function [Срок оценки: Baseline, three and six months]
  • Chemotherapy induced peripheral neuropathy [Срок оценки: Baseline, three and six months]
  • Muscle strength [Срок оценки: Baseline, three and six months]
  • Body composition [Срок оценки: Baseline, three and six months]
  • Muscle strength [Срок оценки: Baseline, three and six months]

Критерии участия

Критерии включения

  • Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or first line palliative chemotherapy for colorectal cancer
  • ≥65 years of age at the time of signing the informed consent form
  • Able to speak and read Danish, and to provide a signed informed consent form
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2

Критерии исключения

  • Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
  • Severe physical disability that hinders physical exercise
  • Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
  • Inability to sign informed content
  • Patients who have had a consultation in the geriatric outpatient clinic within the past six months

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Дания · 2 центра
  • Copenhagen University Hospital - Rigshospitalet — Copenhagen
  • Copenhagen University Hospital - Herlev and Gentofte Hospital — Herlev

Публикации

  • Piper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16. PMID 38631243

Идентификаторы

NCT: NCT05710809 · H-22064206

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗