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

Danish Cancer Society24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

ExerciseBEHAVIORAL

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.

Whole grain ryeBEHAVIORAL

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

RecommendationsBEHAVIORAL

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

Eligibility

Sex: MALEMin age: 55 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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?

Time frame: Five years

Secondary Outcomes

Prostate cancer progression, effect of the life style intervention

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.

Time frame: One year

Insulin sensitivity and insulin secretion, effect of the life style intervention

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.

Time frame: One year

Life quality, effect of the life style intervention

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

Time frame: One year

Metabolic profile, effect of the life style intervention

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.

Data from ClinicalTrials.gov

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