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Brief Title: Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
Official Title: 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.
Study ID: NCT01300104
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Aarhus University, Institute of Sport Science, Aarhus, , Denmark
Counseling Center, Danish Cancer Society, Aarhus, , Denmark
Aarhus University Hospital Skejby, Aarhus, , Denmark
Danish Cancer Society, Copenhagen, , Denmark
Name: Anne Tjønneland, Dr.Med.Sci.
Affiliation: Danish Cancer Society Research Center
Role: STUDY_DIRECTOR
Name: Rikke D Hansen, Dr.
Affiliation: Danish Cancer Society Research Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Borre, Prof.
Affiliation: Aarhus University Hospital Skejby
Role: STUDY_DIRECTOR