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Prescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs.

Restrictions: None.

Exercise

Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.

Whole grain rye

Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

Recommendations

Anne Tjønneland, Dr.Med.Sci.

Rikke D Hansen, Dr.

Michael Borre, Prof.

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.

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.

Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer

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.

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?

PSA is measured at baseline and 3, 6 and 12 months after baseline among all participants. Prostate biopsies are made at baseline and 6 months after baseline among all participants.

Oral glucoce tolerance test is made among all participants at baseline, and 3, 6 and 12 months after baseline.

C peptide levels will be measured in 24h urine samples the following year after the intervention. The urine samples are collected at baseline, and 3, 6 and 12 months after baseline from all participants.

Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.

The following measurements are made at baseline, and 3, 6 and 12 months after baseline among all participants: Bioimpedance, skin fold analysis, waist and hip circumference, weight and height, and blood pressure.

CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer	NCT01300104	Prostate Cancer	Exercise Whole grain rye Recommendations	55 Years - 70 Years	Danish Cancer Society

Spots Global Cancer Trial Database for whole grain rye