The Effect of Endurance Training in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584960
• Other study ID #: H-D-2008-015
• Status: Completed
• Phase: N/A
• First received: April 24, 2012
• Last updated: November 29, 2013
• Start date: April 2008
• Est. completion date: May 2012

Study information

• Verified date: November 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Insulin Resistance
• Insulin Sensitivity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• endurance training
2 years of home-based endurance training

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	PSA doubling time		2 years	No
Secondary	Insulin sensitivity, body composition and inflammation status		0 months, 6 months and 24 months of training	No