The Effect of Endurance Training in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01584960
First received: April 24, 2012
Last updated: November 29, 2013
Last verified: November 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover 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:


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 ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: May 2012
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 Cross over design with a control group with no intervention
Behavioral: endurance training
2 years of home-based endurance training

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 29, 2013
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 October 19, 2014