A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Changes of Peak Oxygen Consumption (VO2peak)
研究概览
简要总结
The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.
详细描述
The ERASE Trial will be a phase II randomized controlled trial. A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness. The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. Based on this sample size, our study has 80% power with a two-tailed alpha <0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to group assignment for the primary outcome of natural killer cell cytotoxic activity and the secondary outcomes of other circulating biomarkers.
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
- •≥18 years of age
- •diagnosed with low or favorable intermediate grade localized PCa defined as PSA less than 10, Gleason Score 3+3 or 3+4 with low volume, and digital rectal examination (DRE) of T1C or T2A
- •initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy)
- •screened for medical clearance for exercise testing and participation in vigorous aerobic exercise
- •residing in a commutable area near Edmonton, Alberta
- •willing to commute to the Behavioural Medicine Fitness Centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program
排除标准
- •having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension)
- •having contraindications for cardiopulmonary stress and/or physical fitness tests
- •currently participating in a structured, vigorous exercise program.
结局指标
主要结局
Changes of Peak Oxygen Consumption (VO2peak)
时间窗: At baseline and 12-week (postintervention)
VO2peak is a measure of cardiopulmonary fitness and a powerful surrogate outcome for cancer-specific and overall survival. VO2peak will be defined as the highest oxygen-uptake value recorded during the test and quantified where participants reach a plateau in oxygen consumption, which will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).
次要结局
- Changes of High-Sensitivity C-Reactive Protein (hs-CRP)(At Baseline and 12-week postintervention)
- Changes of Adiponectin(At Baseline and 12-week postintervention)
- Changes of Insulin(At baseline and 12-week (postintervention))
- Changes of Fasting Glucose(At Baseline and 12-week postintervention)
- Changes of Insulin-like Growth Factor (IGF)-axis(At baseline and 12-week (postintervention))
- Physical Function(At Baseline and 12-week postintervention)
- Health-Related Quality of Life(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Depression(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Fatigue(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Changes of Immune-Related Phenotype(At baseline and 12-week (postintervention))
- Changes of Prostate-Specific Antigen (PSA)(At baseline, 12-week (postintervention))
- Changes of Complete Blood Count with Differential (CBCD)(At baseline and 12-week (postintervention))
- Changes of HbA1c(At Baseline and 12-week postintervention)
- Changes of Pro-Inflammatory Cytokines(At baseline and 12-week (postintervention))
- Fear of Cancer Progression(At baseline, 12-week (postintervention), 6-month, and 12-month)
- General Anxiety(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Perceived Stress(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Physical Activity Level(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts(At baseline and 12-week (postintervention))
- Cancer Worry(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Prostate Cancer-Specific Anxiety(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Body composition(At baseline and 12-week (postintervention))
- Prostate Cancer-Specific Quality of Life(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Self-esteem(At baseline, 12-week (postintervention), 6-month, and 12-month)
- Exercise Motivation(At baseline, 12-week (postintervention), 6-month, and 12-month)