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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676480
• Other study ID #: H-4-2009-102
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: September 3, 2012
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Endurance training
12 weeks of endurance training 3 times per week

Locations

Country	Name	City	State
Denmark	Centre of Inflammation and Metabolism, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Inge Holm	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body composition and insulin sensitivity in response to training		Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training	No