Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer (NILS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Behavioral: Whole grain rye and exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
- Feasibility of a planned Nordic life style intervention [ Time Frame: Five years ] [ Designated as safety issue: No ]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?
- Prostate cancer progression, effect of the life style intervention [ Time Frame: One year ] [ Designated as safety issue: No ]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 [ Time Frame: One year ] [ Designated as safety issue: No ]
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 [ Time Frame: One year ] [ Designated as safety issue: No ]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 [ Time Frame: One year ] [ Designated as safety issue: No ]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 [ Time Frame: One year ] [ Designated as safety issue: No ]CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention group |
Behavioral: Whole grain rye and exercise
Prescriptions: Minimum 170-180g of whole grain rye intake per day and vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs. Restrictions: None. Recommendations: A health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day. The participants will receive individual counseling from a dietician and a sport coach. |
| No Intervention: Control group |
Behavioral: Whole grain rye and exercise
Prescriptions: None Restrictions: None Recommendations: A health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day. The participants will NOT receive any counseling. |
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 will be measured in blood, urine and prostate tissue.
Eligibility| Ages Eligible for Study: | 55 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| Denmark | |
| Aarhus University Hospital Skejby | |
| Aarhus, Denmark, 8200 | |
| Aarhus University, Institute of Sport Science | |
| Aarhus, Denmark, 8000 | |
| Counseling Center, Danish Cancer Society | |
| Aarhus, Denmark, 8000 | |
| Danish Cancer Society | |
| Copenhagen, Denmark, 2100 | |
| Study Director: | Anne Tjønneland, Dr.Med.Sci. | Danish Cancer Society |
| Principal Investigator: | Rikke D Hansen, Dr. | Danish Cancer Society |
| Study Director: | Michael Borre, Prof. | Aarhus University Hospital |
More Information
No publications provided
| Responsible Party: | Rikke Dalgaard Hansen, Principal Investigator / Project Manager, Danish Cancer Society |
| ClinicalTrials.gov Identifier: | NCT01300104 History of Changes |
| Other Study ID Numbers: | EC Grant agreement 242244, CHANCES |
| Study First Received: | February 18, 2011 |
| Last Updated: | January 2, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee |
Keywords provided by Danish Cancer Society:
|
prostate cancer progression active surveillance whole grain rye |
exercise insulin sensitivity quality of life |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Insulin Resistance Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013