Effect of Different Exercise Regimens on Intratumoral Natural Killer (NK) Cell Variability 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
- Variability in intratumoral Natural Killer (NK)-cell infiltration
研究概览
简要总结
Background and purpose: The purpose of this study is to investigate the effect of exercise on intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural killer (NK)-cell infiltration in patients with localized prostate cancer, and that the infiltration is greater in patients performing High Intensity Interval Training compared to usual care controls.
Currently there is a lack of randomized controlled trials examining different types of exercise in patients with localized prostate cancer. 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 High Intensity Interval Training (HIIT) exercise intervention or observational control receiving usual care from inclusion and until planned surgery (radical prostatectomy).
All patients will undergo assessments at inclusion (baseline) and at follow-up after the exercise intervention period (maximum 8 weeks) 3-5 days prior to surgery.
Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality of life by self-report questionnaires; fasting blood sample measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and inflammatory markers.
Biological tissue from tumor (primary prostate biopsies) will 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 exercise on the variability of intratumoral Natural Killer (NK)-cell infiltration in tumor biopsies taken before and after an exercise intervention in patients randomized 2:1 to one of two study arms: I) High Intensity Interval Training (HIIT) (N=20) or II) usual care, prior to radical prostatectomy.
In addition to this the investigators wish to investigate the effect of HIIT exercise on the infiltration of other immune cells into the tumor, tumor vessel morphology, modulation of tumor-metabolism, -biology and signaling.
Finally the aim is to explore the effect of pre-operative HIIT exercise on physiological (e.g. cardiovascular fitness, body composition, metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Pathologically verified localized prostate cancer
- •Eligible for curative radical prostatectomy
排除标准
- •Any other known malignancy requiring active treatment
- •Performance status > 1
- •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
Variability in intratumoral Natural Killer (NK)-cell infiltration
时间窗: Primary prostate biopsies and up to 8 weeks
Natural killer (NK)-cell infiltration will be quantified using histological analyses.
次要结局
- Tumor vessel morphology(Primary prostate biopsies and up to 8 weeks)
- Tumor-metabolism, - biology and signaling(Primary prostate biopsies and up to 8 weeks)
- Changes in immune cells(Baseline and up to 8 weeks)
- Changes in Plasma LDL-Cholesterol concentrations(Baseline and up to 8 weeks)
- Changes in Plasma HDL-Cholesterol concentrations(Baseline and up to 8 weeks)
- Changes in IL-1 concentration(Baseline and up to 8 weeks)
- Changes in Plasma Total-Cholesterol concentrations(Baseline and up to 8 weeks)
- Change in body composition(Baseline and up to 8 weeks)
- Changes in patient-reported Quality of Life - FACT(Baseline and up to 8 weeks)
- Changes in epinephrine concentration(Baseline and up to 8 weeks)
- Changes in nor-epinephrine concentration(Baseline and up to 8 weeks)
- Changes in IL- 2 concentration(Baseline and up to 8 weeks)
- Changes in IL- 6 concentration(Baseline and up to 8 weeks)
- Changes in IL- 8 concentration(Baseline and up to 8 weeks)
- Changes in IL- 10 concentration(Baseline and up to 8 weeks)
- Changes in IL- 15R alpha complex concentration(Baseline and up to 8 weeks)
- Changes in Tumor Necrosis Factor alpha (TNFa) concentration(Baseline and up to 8 weeks)
- Changes in Interferon Gamma (IFNγ) concentration(Baseline and up to 8 weeks)
- Changes in Plasma Triglyceride concentrations(Baseline to and up to 8 weeks)
- Change in VO2peak(Baseline and up to 8 weeks)
- Changes in insulin(Baseline and up to 8 weeks)
- Change in wattmax(Baseline and up to 8 weeks)
- Changes in Physical Activity level(Baseline up to 8 weeks)
- Changes in Sleep Quality(Baseline up to 8 weeks)
- T-cell infiltration(Primary prostate biopsies from baseline and up to 8 weeks)
- Changes in Anxiety and Depression(Baseline up to 8 weeks)
- Changes in HbA1C (fasting blood samples)(Baseline and up to 8 weeks)
研究者
Sissal Sigmundsdóttir Djurhuus
MD, PhD student
Rigshospitalet, Denmark