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| ID | Type | Description | Link |
|---|---|---|---|
| CHANCES | Other Grant/Funding Number | European Commission |
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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| University of Aarhus | OTHER |
| European Commission | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and whole grain rye | Experimental |
| |
| No prescriptions | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Tjønneland, Dr.Med.Sci. | Danish Cancer Society Research Center | Study Director |
| Rikke D Hansen, Dr. | Danish Cancer Society Research Center | Principal Investigator |
| Michael Borre, Prof. | Aarhus University Hospital Skejby | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, Institute of Sport Science | Aarhus | 8000 | Denmark | |||
| Counseling Center, Danish Cancer Society |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28086943 | Derived | Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D006287 | Health Planning Guidelines |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Whole grain rye | Behavioral | Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None. |
|
| Recommendations | Behavioral | Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day. |
|
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 |
| Aarhus |
| 8000 |
| Denmark |
| Aarhus University Hospital Skejby | Aarhus | 8200 | Denmark |
| Danish Cancer Society | Copenhagen | 2100 | Denmark |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |