The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endurance training
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, ADT, Endurance training
Eligibility 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.
Sites / Locations
- Centre of Inflammation and Metabolism, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ADT group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Changes in body composition and insulin sensitivity in response to training
Secondary Outcome Measures
Full Information
NCT ID
NCT01676480
First Posted
January 10, 2012
Last Updated
September 3, 2012
Sponsor
Inge Holm
Collaborators
Herlev Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01676480
Brief Title
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Official Title
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, ADT, Endurance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADT group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
12 weeks of endurance training 3 times per week
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
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 on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
We'll reach out to this number within 24 hrs