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Набор по приглашению NCT06470503

EXercise Enhancement After RadioTherapy for Bone Metastases

Без фазы С лечением Bone Metastases

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: Exercise Program.
Кому может быть актуально
Состояния в реестре: Bone Metastases. Базовые параметры: от 18 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
Канада
Следующий шаг
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Официальное название

EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases

Обзор

The purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (NSBM).

Подробное описание

This study investigates the potential benefits of exercise therapy for patients with bone metastases, a common and often painful complication of cancer. The study aims to determine whether a structured exercise program, in combination with standard of care cancer treatment, can improve physical function, quality of life, and overall well-being for patients undergoing palliative radiotherapy.

Participants will complete a 8-week supervised exercise program delivered virtually through CARE@Home-AC, that is tailored to their individual needs and abilities. The exercises, guided by certified professionals, will focus on improving strength, flexibility, and mobility. Participants will also receive educational sessions covering various aspects of self-management and coping strategies.

The study monitor the safety and feasibility of the exercise program, as well as its impact on pain levels, functional abilities, and quality of life. Follow-up assessments will occur at 1, 3, and 6 months post-intervention to track progress and gather valuable insights into the potential benefits of exercise therapy for individuals with bone metastases.

By exploring the role of exercise in cancer care, this study seeks to empower patients with new tools to manage their symptoms, enhance their well-being, and improve their overall quality of life throughout their cancer journey.

Вмешательства

  • Поведенческое Exercise Program
    8-week program and four-week short maintenance period.

Первичные конечные точки

  • Incidence of toxicities as measured by CTCAE [Срок оценки: Up to 24 weeks]
  • Incidence of skeletal related events (SRE) [Срок оценки: Up to 24 weeks]
  • Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS) [Срок оценки: Up to 24 weeks]
  • Health-related quality-of-life and as measured by the EORTC QLQ C30 [Срок оценки: Up to 24 weeks]
  • Health-related quality-of-life and as measured by the BM22 [Срок оценки: Up to 24 weeks]
  • Change in functional outcomes as measured by 30s sit to stand (STS). [Срок оценки: Up to 24 weeks]
  • Change in functional outcomes as measured by time up and go (TUG) tests. [Срок оценки: Up to 24 weeks]
  • Change in functional outcomes as measured by 6-minute walk test (6MWT) [Срок оценки: Up to 24 weeks]
  • Self-assessment of physical activity as measured by the modified GODIN questionnaire [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

  • Age 18 or older.
  • KPS ≥70
  • Histologically confirmed cancer and radiologically documented NSBM metastases. Spine metastases are allowed if they do not meet the exclusion criteria below.
  • At least one painful NSBM treated with palliative radiotherapy.
  • Independent with ambulation and transfers. Ambulatory aids are permitted.
  • Life expectancy of at least 6 months

Критерии исключения

  • Any untreated metastatic disease that may preclude safely performing physical exercise including:
  • History of leptomeningeal disease
  • Active (untreated/progressive) malignant spinal cord or cauda equina compression
  • Bilsky 2 or 3
  • Neurological compromise secondary to CNS involvement
  • Symptomatic brain metastases prohibiting exercise due to neurological compromise
  • High risk of instability of any boney lesion(s) that may require orthopedic intervention
  • SINS score > 7
  • Mirels score > 6

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06470503 · 24-5379

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗