Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
2 other identifiers
interventional
24
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Feb 2011
Typical duration for not_applicable prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFebruary 19, 2015
February 1, 2015
4 years
February 18, 2011
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Prostate cancer progression, effect of the life style intervention
One year
Insulin sensitivity and insulin secretion, effect of the life style intervention
One year
Life quality, effect of the life style intervention
One year
Metabolic profile, effect of the life style intervention
One year
Inflammation, effect of the life style intervention
One year
Study Arms (2)
Exercise and whole grain rye
EXPERIMENTALNo prescriptions
ACTIVE COMPARATORInterventions
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.
Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.
Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danish Cancer Societylead
- Aarhus University Hospitalcollaborator
- University of Aarhuscollaborator
- European Commissioncollaborator
Study Sites (4)
Aarhus University, Institute of Sport Science
Aarhus, 8000, Denmark
Counseling Center, Danish Cancer Society
Aarhus, 8000, Denmark
Aarhus University Hospital Skejby
Aarhus, 8200, Denmark
Danish Cancer Society
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 28086943DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Tjønneland, Dr.Med.Sci.
Danish Cancer Society Research Center
- PRINCIPAL INVESTIGATOR
Rikke D Hansen, Dr.
Danish Cancer Society Research Center
- STUDY DIRECTOR
Michael Borre, Prof.
Aarhus University Hospital Skejby
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator / Project Manager
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 21, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
February 19, 2015
Record last verified: 2015-02