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The Effect of Endurance Training in Patients With Prostate Cancer

This study is currently recruiting participants.
Verified April 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01584960
First received: April 24, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.


Condition Intervention
Prostate Cancer
Insulin Sensitivity
Body Composition, Beneficial
 Behavioral: endurance training
Behavioral: control group, no behavioral modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • PSA doubling time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity, body composition and inflammation status [ Time Frame: 0 months, 6 months and 24 months of training ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostate cancer, endurance training
Prostate cancer patients doing 2 years of home-based endurance training
 Behavioral: endurance training
2 years of home-based endurance training
No Intervention: Prostate cancer patients
Control group
 Behavioral: control group, no behavioral modification
control group, no behavioral modification

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer patients with an increase in PSA following radical prostatectomy

Exclusion Criteria:

  • severe cardiovascular disease
  • severe arthritis
  • severe neuropathy
  • severe hypertension
  • therapy with antidiabetic agents
  • other treatment for prostate cancer than radical prostatectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584960

Contacts
Contact: Thine Hvid, ph.d.student 35450898 thvid@inflammation-metabolism.dk

Locations
Denmark
Centre of Inflammation and Metabolism, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Thine Hvid, ph.d.student     35450898     thvid@inflammation-metabolism.dk    
Sub-Investigator: Thine Hvid, ph.d.student            
Sponsors and Collaborators
Inge Holm
Herlev Hospital
Investigators
Study Director: Bente K Pedersen Centre of Inflammation and Metabolism, Rigshospitalet
  More Information

No publications provided

Responsible Party: Inge Holm, Administrator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01584960     History of Changes
Other Study ID Numbers: H-D-2008-015
Study First Received: April 24, 2012
Last Updated: April 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Insulin Resistance
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013