Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Hypoxic fraction-gold standard
研究概览
简要总结
Previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.
详细描述
A randomized controlled trial with four to five weeks of moderate/high intensity aerobic exercise program compared with no intervention for 32 prostate cancer patients waiting for radical prostatectomy at the University Hospital of North Norway (UNN). 16 patients will undergo the intervention. The expression of the hypoxic marker pimonidazole in the prostate specimens of intervention groups and the control groups will be assessed. This method is considered a reliable tissue oxygenation measurement technique. These patients will also have their and blood flow and hypoxia measured in prostate cancers through magnetic resonance imaging (MRIs).
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
- •diagnosed PC
- •planned radical prostatectomy
- •informed consent given
- •above 18 years of age
- •BMI < 30
- •non-smoker
- •living in Tromso region
排除标准
- •Contraindications to the intervention like;
- •heart failure,
- •angina pectoris,
- •respiratory disease limiting possible intervention
- •use of physical supportive devices to aid movement
- •High level of physical activity
结局指标
主要结局
Hypoxic fraction-gold standard
时间窗: through study completion, an average of 1 year
We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole
次要结局
- Health related Quality of life(through study completion, an average of 1 year)
- Side effects(through study completion, an average of 1 year)
- Hypoxic fraction-MRI(through study completion, an average of 1 year)