The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tumor hypoxia
研究概览
简要总结
Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise reduces tumor hypoxia and that the reduction is greater in patients performing one acute high intensity exercise bout compared to no training controls.
The investigators have not been able to identify any prior or current randomized trials investigating exercise and tumor hypoxia, and believe that such research is warranted and would be of great importance. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.
Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.
Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either one single acute High Intensity Interval Training bout or usual care and no training the day prior to radical prostatectomy.
All patients will undergo assessment at inclusion (baseline) and the day prior to surgery.
Assessment includes: anthropometrics; blood pressure; resting hearth rate; hip and waist circumference, ECG, quality of life by self-report questionnaires; fasting blood sample measuring PSA (prostate specific antigen), cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose and inflammatory markers.
All patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate.
Biological tissue from tumor (primary prostate biopsies) will also be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.
详细描述
The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer randomized to one single acute I) High Intensity Interval Training bout compared to (II) usual care and no training prior to radical prostatectomy.
In addition to this the aim is to investigate the effect of one exercise bout on tumor vessel morphology and to investigate the effect of one acute exercise bout on intratumoral immune cell infiltration and to investigate the modulation of tumor-metabolism, -biology and signaling in patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
Moreover this study will explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session, and will collect physiological (metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) information regarding patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •Men with histologically verified localized prostate adenocarcinoma undergoing curative intended radical prostatectomy.
排除标准
- •Age: <18 years
- •Any other known malignancy requiring active treatment
- •Performance status > 1
- •Allergy to pimonidazole
- •Ongoing treatment with beta blockers
- •Physical disabilities precluding physical testing and/or exercise
- •Inability to read and understand Danish
结局指标
主要结局
Tumor hypoxia
时间窗: At prostatectomy
Quantification of tumor hypoxia will be assessed using pimonidazole staining
次要结局
- Changes in immune cells during an acute exercise bout(From start of exercise bout and until 60 minutes post exercise)
- Changes in epinephrine concentration(From start of exercise bout and until 60 minutes post exercise)
- HbA1C concentration(Blood sampling on the day of radical prostatectomy)
- Wattmax-test(At baseline assessment)
- Changes in Interferon Gamma (IFNγ) concentration(From start of exercise bout and until 60 minutes post exercise)
- Changes in various interleukines(From start of exercise bout and until 60 minutes post exercise)
- Plasma HDL-Cholesterol concentration(Blood sampling on the day of radical prostatectomy)
- Plasma triglyceride concentrations(Blood sampling on the day of radical prostatectomy)
- Plasma Insulin concentration(Blood sampling on the day of radical prostatectomy)
- Plasma Glucose concentration(Blood sampling on the day of radical prostatectomy)
- Intratumoral immune cell infiltration(Primary prostate biopsies and until radical prostatectomy)
- Changes in Tumor Necrosis Factor alpha (TNFa) concentration(From start of exercise bout and until 60 minutes post exercise)
- Tumor metabolism-, biology and signaling(Primary prostate biopsies and until radical prostatectomy)
- Changes in nor-epinephrine concentration(From start of exercise bout and until 60 minutes post exercise)
- Concentration of C-reactive Protein (CRP)(Blood sampling on the day of radical prostatectomy)
- Total plasma cholesterol concentration(Blood sampling on the day of radical prostatectomy)
- Plasma LDL-Cholesterol concentration(Blood sampling on the day of radical prostatectomy)
- Tumor vessel morphology(Primary prostate biopsies and until radical prostatectomy)
研究者
Sissal Sigmundsdóttir Djurhuus
Principal investigator
Rigshospitalet, Denmark