Exercise for the Treatment of Cancer-Related Sarcopenia

Официальное название

Exercise for the Treatment of Cancer-Related Sarcopenia: a Randomised Controlled Trial.

Обзор

Our primary objective is to assess the effects of exercise on cancer-related sarcopenia and its hallmarks, including muscle strength, muscle mass, and physical performance. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (QoL), cancer-related fatigue, and sleep quality. Additionally, we will explore the effects of exercise on bone and fat mass as secondary outcomes.

Подробное описание

Cancer-related sarcopenia is a distinct and severe form of muscle atrophy, as no other condition (e.g., aging, immobilization, or microgravity) results in such profound impairment in patient prognosis. Sarcopenic cancer patients experience greater fatigue, poorer quality of life, longer hospital stays and higher costs, worse cancer outcomes, and increased mortality compared with non-sarcopenic patients. As no pharmacological treatments are approved for sarcopenia, management relies primarily on nutritional strategies and physical exercise. While exercise effectively prevents and attenuates sarcopenia in older adults, its efficacy in cancer patients remains uncertain.

Cancer-related sarcopenia is a multifactorial condition driven by tumor progression and cancer therapies. Tumors increase nutrient competition and promote hormonal dysregulation and chronic inflammation, impairing muscle protein balance. In addition, chemotherapy and radiotherapy induce oxidative stress and mitochondrial dysfunction, accelerating muscle wasting and contributing to anabolic resistance-a reduced responsiveness of muscle to stimuli such as exercise. These factors may limit exercise-induced gains in muscle mass and strength in cancer patients.

Вмешательства

• Другое Multimodal, supervised exercise training
  The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting major upper and lower body muscle groups to improve muscle strength and mass. Six to eight exercises were performed using body weight, elastic bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the 0-10 Borg rating of perceived exertion when health stat

Первичные конечные точки

• sarcopenia [Срок оценки: baseline, week 24 (post exercise)]

Вторичные конечные точки (9)

• Body composition [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Cardiorespiratory endurance and functional capacity [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Fatigue [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Health-related quality of life (HRQOL) [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Blood markers [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Disease progression [Срок оценки: Up to 1 year after the 48-week intervention period]
• Survival [Срок оценки: Up to 1 year after the 48-week intervention period]
• Safety and exercise program adherence [Срок оценки: Baseline and week 24 (post exercise intervention)]
• Physical activity levels [Срок оценки: Baseline]

Критерии участия

Критерии включения

• > 18 years old women with a confirmed diagnosis of breast or gynecological cancer.
• Any level of sarcopenia (pre-sarcopenia, sarcopenia, or severe sarcopenia).
• Patients must have completed their primary treatment regimen (surgery, chemotherapy, and/or radiotherapy) for at least 2 weeks and up to 2 years before enrolment.
• have received the medical consent to be engaged in physical exercise programs.

Критерии исключения

• The presence of one or more comorbidities that could potentially interfere with attendance or test results (e.g., other cancers or acute or chronic renal failure);
• Already in exercise programs comparable to the HERA program;
• Evidence of severe cardiovascular disease as a result of an electrocardiogram.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• State University of Londrina — Londrina

Идентификаторы

NCT: NCT07498985 · PBA2025201000211 · PBA2025201000211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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