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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Whole grain rye
* Behavioral: Recommendations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and whole grain rye<br> | Behavioral: Exercise<br>* 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.<br>Behavioral: Whole grain rye<br>* Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.<br>Behavioral: Recommendations<br>* Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.<br>|
| Active Comparator: No prescriptions<br> | Behavioral: Recommendations<br>* Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | One year | 
| Inflammation, effect of the life style intervention | CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer progression, active surveillance, whole grain rye, exercise, insulin sensitivity, quality of life