The Physical Exercise and Prostate Cancer Study (PEPC)
This study has been completed.
Sponsor:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00658229
First Posted: April 14, 2008
Last Update Posted: October 15, 2012
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
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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 Intervention Model: Parallel Assignment Masking: None (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:
Further study details as provided by Lene Thorsen, Oslo University Hospital:
Primary Outcome Measures:
- lean body mass [ Time Frame: before ADT, before and after the intervention ]
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 ]
| 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
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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.
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Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 75 Years (Child, Adult, Senior) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | April 8, 2008 |
| First Posted: | April 14, 2008 |
| Last Update Posted: | October 15, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Lene Thorsen, 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 |