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

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300104
• Other study ID #: EC Grant agreement 242244
• Secondary ID: CHANCES
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: February 18, 2015
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Skejby	Aarhus
Denmark	Aarhus University, Institute of Sport Science	Aarhus
Denmark	Counseling Center, Danish Cancer Society	Aarhus
Denmark	Danish Cancer Society	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Danish Cancer Society	Aarhus University Hospital, European Commission, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No