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

NCT ID: NCT01300104

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-02-28

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise and whole grain rye

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Recommendations

Intervention Type: BEHAVIORAL

Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

No prescriptions

Group Type: ACTIVE_COMPARATOR

Recommendations

Intervention Type: BEHAVIORAL

Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.

Interventions

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.

Intervention Type: BEHAVIORAL

Whole grain rye

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Danish Cancer Society

OTHER

Sponsor Role: lead

Responsible Party

Rikke Dalgaard Hansen

Principal Investigator / Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Tjønneland, Dr.Med.Sci.

Role: STUDY_DIRECTOR

Danish Cancer Society Research Center

Rikke D Hansen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Danish Cancer Society Research Center

Michael Borre, Prof.

Role: STUDY_DIRECTOR

Aarhus University Hospital Skejby

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

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 28086943 (View on PubMed)

Other Identifiers

CHANCES

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EC Grant agreement 242244

Identifier Type: -

Identifier Source: org_study_id