CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of self-reported adverse events by arm
研究概览
简要总结
This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of aerobic exercise vs. 12 weeks of resistance exercise vs. usual care in men with metastatic castration resistant prostate cancer to determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and a prognostic score.
详细描述
This is a PI-initiated, randomized clinical trial of 12 weeks of aerobic exercise vs. 12 weeks of resistance exercise vs. usual care among 39 men with metastatic castration resistant prostate cancer. Eligible men will be randomized with equal probability to one of the three regimens. All patients will receive a packet of print material on diet, exercise, and psycho-social support appropriately geared for men with late stage disease at the end of the trial. The aerobic exercise arm (N=13) will receive a 3 day/week remotely-supervised exercise regimen that includes high-intensity interval training and continuous vigorous intensity aerobic exercise training. The resistance exercise arm (N=13) will receive a 3 day/week remotely-supervised resistance exercise regimen incorporating different volumes and loads. Men in the control arm (N=13) will be asked to continue their typical exercise practices for 12 weeks. Subjects will be asked to complete questionnaires, physical function and strength tests, body measurements, and collection of blood specimen at baseline and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Histologically documented adenocarcinoma of the prostate with systemic bone or node metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or luteinising hormone-releasing hormone (LHRH) agonist. Castrate levels of testosterone must be maintained while on study. Men can be enrolled prior to starting abiraterone and/or enzalutamide OR already be receiving treatment with abiraterone and/or enzalutamide.
- •On androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study.
- •≥4 weeks since any major surgery and fully recovered
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Required Initial Laboratory Values:
- •Platelet count ≥ 100,000/microliter (uL)
- •Hepatic and renal dysfunction that would preclude participation in an exercise program, in the opinion of the treating physician
- •Serum testosterone ≤ 50 ng/dL
- •Medical clearance to undergo steep ramp test and completion of steep ramp test
- •Physician consent to participate in vigorous aerobic or resistance exercise training
- •Age ≥18 years
排除标准
- •Men with small cell neuroendocrine tumors or features of small cell disease
- •Chemotherapy criteria: Metastatic castrate-resistant prostate cancer (CRPC) pre-chemo (metastatic castration-resistant adenocarcinoma prostate cancer, pre-CRPC chemotherapy), which is given for hormone-sensitive prostate cancer, is allowed. Metastatic CRPC post- chemo (metastatic castrate-resistant adenocarcinoma prostate cancer, post-CRPC chemotherapy) is allowed with the treating physician's (oncologist) discretion/approval.
- •Poorly controlled hypertension
- •Any contraindications to vigorous exercise, including, but not limited to: brain metastases, current congestive heart failure, serious or non-healing wound, and no serious cardiovascular events within 12 months
- •Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living (can participate with cardiologist clearance)
- •Has difficulty climbing a flight of stairs due to physical impairment
- •Has been recommended by a doctor to only medically supervised activity
- •Has chest pain brought on by physical activity (can participate with cardiologist clearance)
- •Has developed chest pain in the past month (can participate with cardiologist clearance)
- •Serious or non-healing wound, ulcer, or bone fracture
- •Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
- •Serious or non-healing wound, ulcer, or bone fracture.
- •Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
- •Any peripheral neuropathy ≥grade 3
- •Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
- •Men participating in vigorous aerobic exercise for 75 minutes or more per week and/or resistance exercise three or more days per week
- •Men who do not complete the baseline lifestyle and quality-of-life questionnaires
结局指标
主要结局
Number of self-reported adverse events by arm
时间窗: Up to 4 months
Adverse events will be assessed at each weekly coach call, at clinic visits during the study, and at the 12-week study visit. They are continuously reported from informed consent until 28 days after the 12-week study visit.
Attendance at 70% or more of exercise sessions.
时间窗: 3 months
Study feasibility will be determined by the proportion of participants who complete 70 percent or more of all sessions.
Median sessional tolerance
时间窗: Up to 3 months
Exercise tolerance will be assessed by participant self-report of a single question at each exercise session using a 10 point Likert scale with a minimum score of 0=intolerable and a maximum score of 10=highly tolerable.
Adherence at 70% or more of the completed exercise sessions.
时间窗: 3 months
Study feasibility will be determined by the proportion of participants who completed 70 percent or more of the exercise sessions as or more than prescribed.
Study acceptability
时间窗: 3 months
Proportion of participants who were satisfied or very satisfied with the intervention
次要结局
- Number of participants reporting use of opiate pain medication(Up to 3 months)
- Change in objective physical function over time(Up to 3 months)
- Change in objective physical strength over time(Up to 3 months)
- Change in scores on the Expanded Prostate Cancer Index Composite-26 (EPIC-26)(Up to 3 months)
- Change in scores on the EuroQol Five-Dimensional Questionnaire (EQ-5D)(Up to 3 months)
- Change in scores on the Fatigue visual analog scale (VAS)(3 months)
- Change in scores on the Bone pain visual analog scale (VAS)(Up to 3 months)
- Change in Scores on the Brief-Pain Inventory Short Form (BPI-SF)(Up to 3 months)
- Change in scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) over time(Up to 3 months)
- Change in scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(Up to 3 months)
- Change in scores on the State-Trait Anxiety Inventory for Adults (STAI)(Up to 3 months)
- Change in Scores on the Center for Epidemiological Studies Depression Scale (CESD)(Up to 3 months)
- Change in scores on the Pittsburgh Sleep Quality Index (PSQI) over time(Up to 3 months)
- Change in FACT-General (FACT-G) social/family wellbeing domain.(3 months)