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The Physical Exercise and Prostate Cancer Study (PEPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658229
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 15, 2012
Sponsor:
Collaborators:
Ullevaal University Hospital
Norwegian School of Sport Sciences
University of Alberta, Physical Education
University of Oslo
Norwegian Foundation for Health and Rehabilitation
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Lene Thorsen, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE April 8, 2008
First Posted Date  ICMJE April 14, 2008
Last Update Posted Date October 15, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
lean body mass [ Time Frame: before ADT, before and after the intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
lean body mass [ Time Frame: before ADT, before and after the intervention and 12 months after the intervention ]
Change History Complete list of historical versions of study NCT00658229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
bone mineral density, fat mass, body mass index, serological outcomes (including lipids, hormones and CRP), physical functioning, psycho-social functioning and muscle cellular outcomes (including muscle fiber size and function) [ Time Frame: before ADT, before and after the intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
bone density, body fat, physical function, lipids, hormones, muscle satellite cells, depression, fatigue and health-related quality of life [ Time Frame: before ADT, before and after the intervention and 12 months after the intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Physical Exercise and Prostate Cancer Study
Official Title  ICMJE Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial
Brief Summary The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Behavioral: Strength training group
After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).
Other Name: Exercise, Physical activity
Study Arms  ICMJE
  • Experimental: Strength training group
    A four months strength training program during androgen deprivation therapy for prostate cancer patietns.
    Intervention: Behavioral: Strength training group
  • No Intervention: Control group
    Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment.
Publications * Thorsen L, Nilsen TS, Raastad T, Courneya KS, Skovlund E, Fosså SD. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design. BMC Cancer. 2012 Mar 29;12:123. doi: 10.1186/1471-2407-12-123.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2012)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2008)
132
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
  • Referred to RH and UUS for radiotherapy
  • < 75 years
  • Capable of reading and writing Norwegian
  • Treating oncologist must approve of the subjects' participation
  • Living within approximately 1 hour from Oslo by car or public transportation

Exclusion Criteria:

  • Routinely resistance training with manuals
  • Medication for osteoporosis (i.e. bisphosphonates)
  • Conditions of a severity that contraindicate exercise without adjusted actions
  • Mentally incompetent conditions
  • Conditions of a severity that complicates the ability to participate in a supervised training program
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658229
Other Study ID Numbers  ICMJE REK - 08/212b
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lene Thorsen, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Ullevaal University Hospital
  • Norwegian School of Sport Sciences
  • University of Alberta, Physical Education
  • University of Oslo
  • Norwegian Foundation for Health and Rehabilitation
  • The Royal Norwegian Ministry of Health
Investigators  ICMJE
Principal Investigator: Lene Thorsen, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP