Clinical trial NCT01300104: Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer progression
active surveillance
whole grain rye
exercise
insulin sensitivity
quality of life
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: University of Aarhus
name: European Commission
First posted: 2011-02-21
Enrollment: 24
Sex: MALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of a planned Nordic life style intervention
timeFrame: Five years
Secondary outcomes:
measure: Prostate cancer progression, effect of the life style intervention
timeFrame: One year
measure: Insulin sensitivity and insulin secretion, effect of the life style intervention
timeFrame: One year
measure: Life quality, effect of the life style intervention
timeFrame: One year
measure: Metabolic profile, effect of the life style intervention
timeFrame: One year
measure: Inflammation, effect of the life style intervention
timeFrame: One year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Institute of Sport Science
city: Aarhus
country: Denmark
facility: Counseling Center, Danish Cancer Society
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby
city: Copenhagen
country: Denmark
facility: Danish Cancer Society
Study officials:
affiliation: Danish Cancer Society Research Center
name: Anne Tjønneland, Dr.Med.Sci.
role: STUDY_DIRECTOR
affiliation: Danish Cancer Society Research Center
name: Rikke D Hansen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital Skejby
name: Michael Borre, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.