The Physical Exercise and Prostate Cancer Study (PEPC)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Strength training group	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
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
Study Start Date :	November 2008
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. lean body mass [ Time Frame: before ADT, before and after the intervention ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

Responsible Party:	Lene Thorsen, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00658229 History of Changes
Other Study ID Numbers:	REK - 08/212b
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