Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall quality of life
研究概览
简要总结
This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.
详细描述
Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause adverse effects reducing quality of life. Most common adverse effects include fatigue, weight gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.
Regular exercise, especially programs involving combination of both aerobic exercise and resistance training has been shown to reduce to reduce adverse effects of ADT on physical functioning and quality of life. It may also improve disease prognosis.
The study compares effects of supervised and unsupervised exercise on plasma lipid parameters (total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose, glycated hemoglobin), overall quality of life and on average daily exercise activity in men with prostate cancer and under ADT. As secondary outcome we will study effect on continued exercise activity after the intervention, changes in body composition, blood pressure and risk of fractures, castration resistance as well as death due to prostate cancer and due to any cause.
Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose parameters and increase daily exercise activity more that non-supervised exercise. We also expect higher continued exercise activity, greater changes in body composition and blood pressure and lowered risk of fractures and death in the supervised exercise group.
This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to inform further larger trial.
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
- 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
- •Undergoing castration treatment for prostate cancer
- •Informed consent for the study
排除标准
- •Unable to participate in exercise (ECOG 2 or greater)
- •High bone fracture risk (as judged by the primary physician)
- •Unable to understand spoken and written instructions in Finnish
研究组 & 干预措施
Supervised exercise arm
Informational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise.
干预措施: Lecture (Other)
Supervised exercise arm
Informational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise.
干预措施: Progressive supervised weight training (Other)
Non-supervised exercise arm
Informational initiation lecture and only non-supervised exercise
干预措施: Lecture (Other)
结局指标
主要结局
Overall quality of life
时间窗: At randomization and twice more at 12 week intervals
Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life
Fasting plasma HDL cholesterol
时间窗: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma glucose level
时间窗: At randomization and twice more at 12 week intervals
Value measured in mmol/l
Daily total activity
时间窗: At randomization and twice more at 12 week intervals
Daily activity as measured by wrist activity monitor worn by the participants at all times during the study. Measured as metabolic equivalents of task (MET) units. Range from 0.9 to 23.
Fasting plasma triglycerides
时间窗: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma total cholesterol
时间窗: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Blood glycated hemoglobin (HbA1C) level
时间窗: At randomization and twice more at 12 week intervals
Value measured in mmol/mol
Prostate cancer-specific quality of life
时间窗: At randomization and twice more at 12 week intervals
Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life
Fasting plasma LDL cholesterol
时间窗: At randomization and twice more at 12 week intervals
Value measure in mmol/l
次要结局
- Systolic blood pressure(At randomization and twice more at 12 week intervals)
- Metabolic age(At randomization and twice more at 12 week intervals)
- Muscle mass(At randomization and twice more at 12 week intervals)
- Fat mass(At randomization and twice more at 12 week intervals)
- Diastolic blood pressure(At randomization and twice more at 12 week intervals)
- Change in daily activity after the intervention(Measured daily for 12 weeks' time after the intervention)
- Skeletal mass(At randomization and twice more at 12 week intervals)
- Subjective adverse effects of castration treatment(At randomization and twice more at 12 week intervals)
- Lean body mass(At randomization and twice more at 12 week intervals)