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Completed

NCT Number: NCT01300104

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

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Motor Activity Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital Skejby, Aarhus, Denmark

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About this study

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 are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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.

Whole grain rye

Behavioral

Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.

recommendations

Behavioral

Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

Primary outcomes

  1. Feasibility of a planned Nordic life style intervention

    Time frame: Five years

    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 outcomes

  1. Prostate cancer progression, effect of the life style intervention

    Time frame: One year

    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.

  2. Insulin sensitivity and insulin secretion, effect of the life style intervention

    Time frame: One year

    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.

  3. Life quality, effect of the life style intervention

    Time frame: One year

    Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.

  4. Metabolic profile, effect of the life style intervention

    Time frame: One year

    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.

  5. Inflammation, effect of the life style intervention

    Time frame: One year

    CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Aarhus University Hospital
  • European Commission
  • University of Aarhus

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2011
Registry last updated
Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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