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The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

This study has been completed.
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01676480
First received: January 10, 2012
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.


Condition Intervention
Prostate Cancer
 Behavioral: Endurance training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Changes in body composition and insulin sensitivity in response to training [ Time Frame: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADT group Behavioral: Endurance training
12 weeks of endurance training 3 times per week
Experimental: Control group Behavioral: Endurance training
12 weeks of endurance training 3 times per week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prostate cancer patients receiving ADT for at least 3 months
  • Healthy age and BMI matched controls

Exclusion Criteria:

  • severe cardiovascular disease
  • severe arthritis
  • severe neuropathy
  • severe hypertension
  • therapy with antidiabetic agents
  • VO2max > 30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676480

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: NCT01676480     History of Changes
Other Study ID Numbers: H-4-2009-102
Study First Received: January 10, 2012
Last Updated: September 3, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Prostate cancer
ADT
Endurance training

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 19, 2013