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

Sponsor

Danish Cancer Society (Other)

Overall Status

Completed

CT.gov ID

NCT01300104

Collaborator

Aarhus University Hospital (Other), University of Aarhus (Other), European Commission (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: Exercise Behavioral: Whole grain rye Behavioral: Recommendations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility of a planned Nordic life style intervention [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 Outcome Measures

Prostate cancer progression, effect of the life style intervention [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.
Insulin sensitivity and insulin secretion, effect of the life style intervention [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.
Life quality, effect of the life style intervention [One year]
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 [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.
Inflammation, effect of the life style intervention [One year]
CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Aarhus University, Institute of Sport Science	Aarhus	Denmark	8000
2	Counseling Center, Danish Cancer Society	Aarhus	Denmark	8000
3	Aarhus University Hospital Skejby	Aarhus	Denmark	8200
4	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 Research Center
Principal Investigator: Rikke D Hansen, Dr., Danish Cancer Society Research Center
Study Director: Michael Borre, Prof., Aarhus University Hospital Skejby