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.
55 Years
70 Years
Male
Prostate Cancer
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of a planned Nordic life style intervention
Outcome Description:
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?
Outcome Time Frame:
Five years
Safety Issue:
No
Principal Investigator
Anne Tjønneland, Dr.Med.Sci.
Investigator Role:
Study Director
Investigator Affiliation:
Danish Cancer Society
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
EC Grant agreement 242244
NCT ID:
NCT01300104
Start Date:
February 2011
Completion Date:
February 2016
Related Keywords:
- Prostate Cancer
- prostate cancer progression
- active surveillance
- whole grain rye
- exercise
- insulin sensitivity
- quality of life
- Prostatic Neoplasms
- Insulin Resistance
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