Back to resultsThe Effect of Endurance Training in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer, Insulin Sensitivity, Body Composition, Beneficial
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
endurance training
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility 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
Sites / Locations
- Centre of Inflammation and Metabolism, Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prostate cancer, endurance training
Arm Description
Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention
Outcomes
Primary Outcome Measures
PSA doubling time
Secondary Outcome Measures
Insulin sensitivity, body composition and inflammation status
Full Information
NCT ID
NCT01584960
First Posted
April 24, 2012
Last Updated
November 29, 2013
Sponsor
Inge Holm
Collaborators
Herlev Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01584960
Brief Title
The Effect of Endurance Training in Patients With Prostate Cancer
Official Title
The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inge Holm
Collaborators
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Insulin Sensitivity, Body Composition, Beneficial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate cancer, endurance training
Arm Type
Experimental
Arm Description
Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention
Intervention Type
Behavioral
Intervention Name(s)
endurance training
Intervention Description
2 years of home-based endurance training
Primary Outcome Measure Information:
Title
PSA doubling time
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Insulin sensitivity, body composition and inflammation status
Time Frame
0 months, 6 months and 24 months of training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente K Pedersen
Organizational Affiliation
Centre of Inflammation and Metabolism, Rigshospitalet
Official's Role
Study Director
Facility Information:
Facility Name
Centre of Inflammation and Metabolism, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Endurance Training in Patients With Prostate Cancer
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