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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Exercise; Behavioral: Whole grain rye; Behavioral: Recommendations

• Registration Number: NCT01300104
• Lead Sponsor: Danish Cancer Society

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and whole grain rye	Whole grain rye	-
Exercise and whole grain rye	Exercise	-
Exercise and whole grain rye	Recommendations	-
No prescriptions	Recommendations	-

Primary Outcome Measures

Name	Time	Method
Feasibility of a planned Nordic life style intervention	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?

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity and insulin secretion, effect of the life style intervention	One year	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, effect of the life style intervention	One year	Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.
Metabolic profile, effect of the life style intervention	One year	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.
Prostate cancer progression, effect of the life style intervention	One year	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.
Inflammation, effect of the life style intervention	One year	CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.

Trial Locations

Locations (4)

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