Low to Moderate Load Power Training as an Exercise Intervention for Men With Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if a low to moderate load power training program is feasible and effective for improving fitness and quality of life of people with prostate cancer under androgen suppression therapy and bone or lymph node metastasis. The main questions it aims to answer are:
- Does a low to moderate load power training program improve quality of life in people with metastatic prostate cancer under androgen deprivation therapy?
- Does a low to moderate load power training program improve power, strength, endurance, and balance in people with metastatic prostate cancer under androgen deprivation therapy?
Researchers will compare the exercise program with routine care to see if power training works to improve common physical side effects of androgen suppression therapy in patients with metastatic prostate cancer.
Participants will:
- Participate in a supervised exercise program twice a week for 6 months or maintain routine care.
- Perform fitness tests and questionnaires about quality of life and mental health.
- Those who take part in the exercise program will also perform semi-structured in-depth interviews after the end of the program.
详细描述
Background and Rationale:
Prostate cancer is the most frequently diagnosed cancer among men worldwide, particularly affecting older populations, with increasing incidence and prevalence projected in the coming decades. While survival rates have improved substantially, these advances have not been matched by improvements in long-term quality of life. A significant proportion of patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), which reduces testosterone levels to control tumor progression.
Despite its effectiveness, ADT is associated with multiple adverse effects, including loss of muscle mass and strength, increased adiposity, decreased bone mineral density, chronic fatigue, and metabolic alterations. These changes resemble an accelerated aging process and increase the risk of sarcopenia, osteoporosis, and functional dependency. In addition, ADT has been linked to psychological disturbances, including depression, anxiety, cognitive impairment, and reduced vitality.
Health-related quality of life (HRQoL) is a multidimensional construct encompassing physical, psychological, and social domains. In prostate cancer patients undergoing ADT, quality of life is significantly impaired due to the combined effects of disease burden and treatment-related side effects. Mental health plays a central role in this construct, as cancer diagnosis and treatment are highly stressful experiences that can disrupt identity, autonomy, and life continuity.
Exercise has been identified as an effective non-pharmacological intervention for mitigating many of the adverse effects of ADT. Systematic reviews and meta-analyses have demonstrated that exercise improves muscle strength, cardiorespiratory fitness, functional performance, fatigue, and body composition in this population. Exercise has also been associated with improvements in quality of life and emotional well-being, particularly when interventions are supervised and long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed diagnosis of prostate adenocarcinoma.
- •Metastatic hormone-sensitive prostate cancer (mHSPC), defined as:
- •Presence of metastases at initial diagnosis (synchronous mHSPC), or
- •Development of metastatic disease following prior treatment with curative intent (surgery and/or radiotherapy) (metachronous mHSPC).
- •Evidence of progression to castration-resistant prostate cancer (CRPC).
- •Ongoing treatment with a doublet regimen consisting of standard androgen deprivation therapy (ADT) in combination with an androgen receptor signaling inhibitor (ARSI), initiated prior to study enrollment.
- •Receipt of bone-protective therapy, including calcium and vitamin D supplementation in combination with bisphosphonates.
- •Presence of metastatic involvement limited to bone and/or lymph nodes.
- •Functionally independent in activities of daily living.
排除标准
- •Evidence of visceral metastatic disease.
- •Current or prior treatment with a triplet regimen that includes chemotherapy.
- •History of pathological fracture.