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.
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 will be measured in blood, urine and prostate tissue.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of a planned Nordic life style intervention
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?
Anne Tjønneland, Dr.Med.Sci.
Danish Cancer Society
Denmark: Danish Dataprotection Agency
EC Grant agreement 242244