Clinical trial · Interventional
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
| Recommendations | Behavioral | — | UNRESOLVED |
| Whole grain rye | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and whole grain rye
- interventionNames
- Behavioral: Exercise
- Behavioral: Whole grain rye
- Behavioral: Recommendations
- type
- ACTIVE_COMPARATOR
- label
- No prescriptions
- interventionNames
- Behavioral: Recommendations
Primary outcomes (1)
- measure
- Feasibility of a planned Nordic life style intervention
- timeFrame
- Five years
- 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?
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEriksen 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 28086943