Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- adherence
研究概览
简要总结
This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT.
Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits.
The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.
At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ).
The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly.
For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years.
Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostatic adenocarcinoma;
- •Metastatic disease candidate to ADT treatment and ADT free;
- •ECOG PS 0-1.
排除标准
- •Physical conditions that may limit adherence to the study (heart failure NYHA 3-4, pathologic fractures, previous disability limiting exercise, etc);
- •Psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.)
- •Other concomitant active malignancies
研究组 & 干预措施
rehabilitation + standard of care (SOC)
All enrolled patients will start a supervised rehabilitation program for 12 weeks
干预措施: rehabilitation (Procedure)
结局指标
主要结局
adherence
时间窗: 12 weeks
Defined as percentage of patients who complete treatment schedule ≥ 75%
次要结局
- physical activity (PA)(baseline, 12 weeks, 24 weeks, 12 months)
- physical performance(baseline, 12 weeks, 24 weeks, 12 months)
- fatigue(12 weeks, 24 weeks, 12 months)
- retention rates(12 weeks, 24 weeks, 12 months)
- Safety and Tolerability(baseline, 12 weeks, 24 weeks, 12 months)
- hand grip strength (HGS)(baseline, 12 weeks, 24 weeks, 12 months)
- recruitment rate(12 weeks, 24 weeks, 12 months)
- retention rates(12 weeks, 24 weeks, 12 months)
- Safety and Tolerability(baseline, 12 weeks, 24 weeks, 12 months)
- hand grip strength (HGS)(baseline, 12 weeks, 24 weeks, 12 months)
- physical performance(baseline, 12 weeks, 24 weeks, 12 months)
- physical activity (PA)(baseline, 12 weeks, 24 weeks, 12 months)
- fatigue(12 weeks, 24 weeks, 12 months)