The Physical Exercise and Prostate Cancer Study (PEPC)

October 12, 2012 updated by: Lene Thorsen, Oslo University Hospital

Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oslo
      • Montebello, Oslo, Norway, 0310
        • Rikshospitalet- Radiumhospitalet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lean body mass
Time Frame: before ADT, before and after the intervention
before ADT, before and after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
before ADT, before and after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
Ullevaal University Hospital
Norwegian School of Sport Sciences
The Royal Norwegian Ministry of Health
University of Alberta, Physical Education
Norwegian Foundation for Health and Rehabilitation

Investigators

  • Principal Investigator: Lene Thorsen, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 12, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK - 08/212b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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