Prostate Cancer
Conditions
Keywords
prostate cancer progression, active surveillance, whole grain rye, exercise, insulin sensitivity, quality of life
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.
Interventions
BEHAVIORALExercise
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.
BEHAVIORALWhole grain rye
Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.
BEHAVIORALRecommendations
Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
Sponsors
Aarhus University Hospital
University of Aarhus
European Commission
Danish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Denmark
Outcome results
None listed