The Physical Exercise and Prostate Cancer Study - Full Text View

The Physical Exercise and Prostate Cancer Study (PEPC)

This study is not yet open for participant recruitment.
Verified by Rikshospitalet-Radiumhospitalet HF, April 2008

Sponsors and Collaborators:	Rikshospitalet-Radiumhospitalet HF 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:	Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier:	NCT00658229

Purpose

The purpose of this study is to determine the effect of a four months strength-training program on physical and psychological health in patients with prostate cancer during androgen deprivation. It is hypothesized is a beneficial effect of the strength-training intervention on physical and psychological health in patients with prostate cancer during androgen deprivation.

Condition	Intervention	Phase
Prostate Cancer	Behavioral: Strength training	Phase III

MedlinePlus related topics:

Cancer Exercise and Physical Fitness Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation - A Randomized Trial

Further study details as provided by Rikshospitalet-Radiumhospitalet HF:

Primary Outcome Measures:

lean body mass [ Time Frame: before ADT, before and after the intervention and 12 months after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Behavioral: Strength training Patients in the exercise group will 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 eight strength-training exercises, with 6-10 repetitions carried out at 60% to 85% of one-repetition maximum (1-RM: the maximum amount of weight that can be lifted once).
B: No Intervention

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
< 75 years
Treating oncologist must approve of the subjects' participation

Exclusion Criteria:

Routinely resistance training with manuals
Conditions of a severity that contraindicate exercise without adjusted actions
Conditions of a severity that complicates the ability to participate in a supervised training program

Contacts and Locations

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

Contacts


Contact: Lene Thorsen, PhD	+47 22935181	lene.thorsen@radiumhospitalet.no

Contact: Sophie D Fosså, Prof.	+47 22934000	sophie.dorothea.fossa@radiumhospitalet.no

Locations


Norway, Oslo
	Rikshospitalet- Radiumhospitalet HF	Not yet recruiting
	Montebello, Oslo, Norway, 0310
	Contact: Lene Thorsen, PhD + 47 22935181 lene.thorsen@radiumhospitalet.no
	Principal Investigator: Lene Thorsen, PhD

Sponsors and Collaborators

Rikshospitalet-Radiumhospitalet HF

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	Rikshospitalet-Radiumhospitalet HF

More Information

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Lene Thorsen, PhD )
Study ID Numbers:	REK - 08/212b
First Received:	April 8, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00658229
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet-Radiumhospitalet HF:

Exercise

Prostatic

Neoplasm

Androgen

Deprivation

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 17, 2008