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The Physical Exercise and Prostate Cancer Study (PEPC)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00658229
First received: April 8, 2008
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose
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.

Condition Intervention Phase
Prostate Cancer
 Behavioral: Strength training group
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • lean body mass [ Time Frame: before ADT, before and after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 60
Study Start Date: November 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training group
A four months strength training program during androgen deprivation therapy for prostate cancer patietns.
 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
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.

  Eligibility
Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658229

Locations
Norway
Rikshospitalet- Radiumhospitalet HF
Montebello, Oslo, Norway, 0310
Sponsors and Collaborators
Oslo University Hospital
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
Principal Investigator: Lene Thorsen, PhD Oslo University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lene Thorsen, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00658229     History of Changes
Other Study ID Numbers: REK - 08/212b 
Study First Received: April 8, 2008
Last Updated: October 12, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Exercise
Prostatic
Neoplasm
Androgen
Deprivation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016