Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer (NILS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aarhus University Hospital
University of Aarhus
European Commission
Information provided by (Responsible Party):
Rikke Dalgaard Hansen, Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT01300104
First received: February 18, 2011
Last updated: January 2, 2012
Last verified: January 2012
  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.

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300104

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
Sponsors and Collaborators
Danish Cancer Society
Aarhus University Hospital
University of Aarhus
European Commission
Investigators
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 Skejby
  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 April 15, 2014