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

Danish Cancer Society

Status

Completed

Conditions

Prostate Cancer

Treatments

Behavioral: Exercise

Behavioral: Whole grain rye

Behavioral: Recommendations

Study type

Interventional

Funder types

Other

Identifiers

NCT01300104

EC Grant agreement 242244

CHANCES (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

55 to 70 years old

Volunteers

No 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