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Spots Global Cancer Trial Database for Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer

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Trial Identification

Brief Title: 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 ID: NCT01300104

Conditions

Prostate Cancer

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.

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

Minimum Age: 55 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Aarhus University, Institute of Sport Science, Aarhus, , Denmark

Counseling Center, Danish Cancer Society, Aarhus, , Denmark

Aarhus University Hospital Skejby, Aarhus, , Denmark

Danish Cancer Society, Copenhagen, , Denmark

Contact Details

Name: Anne Tjønneland, Dr.Med.Sci.

Affiliation: Danish Cancer Society Research Center

Role: STUDY_DIRECTOR

Name: Rikke D Hansen, Dr.

Affiliation: Danish Cancer Society Research Center

Role: PRINCIPAL_INVESTIGATOR

Name: Michael Borre, Prof.

Affiliation: Aarhus University Hospital Skejby

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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