NCT01300104

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Danish Cancer Society · Academic / Other
• Sex: Male
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	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.
BEHAVIORAL	Whole grain rye	Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.
BEHAVIORAL	Recommendations	Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-02-21
• Last updated: 2015-02-19

Locations

4 sites across 1 country: Denmark