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.

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Whole grain rye; Behavioral: Recommendations

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 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Institute of Sport Science
  • Aarhus, Denmark, 8000
    • Counseling Center, Danish Cancer Society
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital Skejby
  • Copenhagen, Denmark, 2100
    • Danish Cancer Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and whole grain rye	Behavioral: Exercise; 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.; Behavioral: Whole grain rye; Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.; Behavioral: Recommendations; Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
Active Comparator: No prescriptions	Behavioral: Recommendations; Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate cancer progression, effect of the life style intervention	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.	One year
Insulin sensitivity and insulin secretion, effect of the life style intervention	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.	One year
Life quality, effect of the life style intervention	Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.	One year
Metabolic profile, effect of the life style intervention	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.	One year
Inflammation, effect of the life style intervention	CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.	One year

Collaborators and Investigators

• Sponsor: Danish Cancer Society
• Collaborators: Aarhus University Hospital; University of Aarhus; European Commission
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 19, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: exercise; quality of life; insulin sensitivity; active surveillance; prostate cancer progression; whole grain rye
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: EC Grant agreement 242244; CHANCES (Other Grant/Funding Number: European Commission)