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The Effect of Endurance Training in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01584960
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Prostate Cancer Insulin Sensitivity Body Composition, Beneficial Behavioral: endurance training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2008
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Prostate cancer, endurance training
Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention
Behavioral: endurance training
2 years of home-based endurance training


Outcome Measures

Primary Outcome Measures :
  1. PSA doubling time [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Insulin sensitivity, body composition and inflammation status [ Time Frame: 0 months, 6 months and 24 months of training ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584960


Locations
Denmark
Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Inge Holm
Herlev Hospital
Investigators
Study Director: Bente K Pedersen Centre of Inflammation and Metabolism, Rigshospitalet
More Information

Responsible Party: Inge Holm, Administrator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01584960     History of Changes
Other Study ID Numbers: H-D-2008-015
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

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