Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients: a Phase I Prescription Dose Escalation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose based on tolerance
研究概览
简要总结
Recent drug improvement (e.g. abiraterone or enzalutamide) for castration resistant prostate cancer (CRPC) patients has improved survival. As treatment strategies improve and patients live longer, patients must cope with their treatment-induced adverse effects. Improving levels of physical activity (PA) and less amounts of sitting time (e.g. sedentary behavior, SB) could have a positive impact on patient's health, non-cancer mortality, and quality of life and potentially improve survival.
The role of PA has not yet been examined in CRPC patients, which is a clear unmet need. No specific PA guidelines exist for CRPC patients, but specific guidelines are warranted because of advanced disease stage, reduced performance score and comorbidity. It is to be expected that the PA level of CRPC patients is lower compared to non-CRPC patients receiving androgen deprivation therapy (ADT).
This study aims to determine the optimal starting physical therapy prescription in CRPC patients receiving second line hormone treatment.
详细描述
CRPC patients receiving second-line hormone treatment at Ghent University Hospital are invited to participate in this phase I 3+3 dose escalation design (escalation to next exercise dose per 3 study patients). The prescription start dose is 15min. aerobic training (50-80% maximum heart rate (HRmax). warm-up and cooling-down and 65-80%HRmax. core), 1 set with 8-10 reps. resistance training (50-60% one repetition maximum (1RM), 8 exercises) and 1 set (30s.) with 2 reps. flexibility training (5 exercises). Factors determining compliance for the dose are tolerance and safety. Tolerance for the exercise prescription will be assessed with the Borg scale of perceived exertion after every exercise. Compliant for tolerance is a score ≤16. Safety will be assessed by the visual analogue scale (VAS) (assessed by the patient) for pain and the CTCAE criteria (assessed by a trained health care provider) for bone pain after every exercise. Compliant for safety is ≤3 VAS for exercise-induced pain and <grade 2 according to the CTCAE criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •CRPC patients with second-line hormone treatment
- •Able to walk 400 meters without help from another person
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
- •≥4 weeks since any major surgery and fully recovered before patient registration
- •Written informed consent must be given according to International conference on harmonization Good Clinical Practice and national regulation.
排除标准
- •Musculoskeletal, cardiovascular or neurological comorbidity that prevent the patient to participate in an exercise program
- •Painful bone metastases (VAS) at the time of inclusion
- •Unstable bone metastases (SINS classification) at time of inclusion
结局指标
主要结局
Maximum tolerated dose based on tolerance
时间窗: change before and after 1 exercise session (at one day)
Maximum tolerated dose will be assessed by borg scale of perceived exertion.
Maximum tolerated dose based on safety
时间窗: change before and after 1 exercise session (at one day)
Maximum tolerated dose will be assessed by CTCAE
次要结局
- Motivation 1(baseline)
- Physical activity level by International Physical Activity Questionnaire (IPAQ)(baseline)
- Physical performance(baseline)
- Body composition(baseline)
- Pain(baseline)
- Functionality(baseline)
- Health Related quality of Life general(baseline)
- Health Related quality of Life disease specific(baseline)
- Physical performance by 6 m walk backward(baseline)
- Physical activity level by Godin(baseline)
- Physical performance by time up and go(baseline)
- Balance by four square test(baseline)
- Balance by chair rise test(baseline)
- Physical performance by 6m walk(baseline)
- Physical performance by Cardiopulmonary Exercise Testing (CPET)(baseline)
- Motivation 2(baseline)