Feasibility Study on a Nordic Lifestyle Intervention Trial Investigating the Effect of Vigorous Activity and Intake of Whole Grain Rye on Cancer Progression, Insulin Sensitivity and Inflammation Among Men With Early Stage Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Feasibility of a planned Nordic life style intervention
研究概览
简要总结
PURPOSE:
To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.
Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.
详细描述
In the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken.
Furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study.
Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer within 2 years prior to enrolment
- •PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
- •Maximum 1/5 tumor positive biopsy rate
- •On active surveillance (elected to forgo treatment)
- •Level of testosterone normal in sera
排除标准
- •Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
- •Less than 10 years of life expectancy
- •Conditions or behaviors likely to affect the capability of participating fully in the intervention
- •Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
- •Gluten intolerance
- •Inflammatory bowel disease (e.g. Crohn, colitis)
- •Physical handicaps
结局指标
主要结局
Feasibility of a planned Nordic life style intervention
时间窗: Five years
Feasibility of an intervention trial is evaluated among Danish men with early stage prostate cancer. Enrollment of participants, possible for this particular type of trial among the particular patient group? Compliance with intervention, obtainable for intervention participants with the tools planned (counseling sessions, exercise programs, supply of rye products, sphygmographs and pedometers)? Does the design minimize drop out? Is the schedule for monitoring, counseling, testing and collection of biological samples efficient and feasible for the research team and for the participants?
次要结局
- Insulin sensitivity and insulin secretion, effect of the life style intervention(One year)
- Life quality, effect of the life style intervention(One year)
- Metabolic profile, effect of the life style intervention(One year)
- Prostate cancer progression, effect of the life style intervention(One year)
- Inflammation, effect of the life style intervention(One year)
研究者
Rikke Dalgaard Hansen
Principal Investigator / Project Manager
Danish Cancer Society