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The Physical Exercise and Prostate Cancer Study (PEPC)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Strength training group
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Exercise, Prostatic, Neoplasm, Androgen, Deprivation

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rikshospitalet- Radiumhospitalet HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strength training group

Control group

Arm Description

A four months strength training program during androgen deprivation therapy for prostate cancer patietns.

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.

Outcomes

Primary Outcome Measures

lean body mass

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)

Full Information

First Posted
April 8, 2008
Last Updated
October 12, 2012
Sponsor
Oslo University Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT00658229
Brief Title
The Physical Exercise and Prostate Cancer Study
Acronym
PEPC
Official Title
Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Exercise, Prostatic, Neoplasm, Androgen, Deprivation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training group
Arm Type
Experimental
Arm Description
A four months strength training program during androgen deprivation therapy for prostate cancer patietns.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength training group
Other Intervention Name(s)
Exercise, Physical activity
Intervention Description
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).
Primary Outcome Measure Information:
Title
lean body mass
Time Frame
before ADT, before and after the intervention
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Thorsen, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet- Radiumhospitalet HF
City
Montebello
State/Province
Oslo
ZIP/Postal Code
0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22458865
Citation
Thorsen L, Nilsen TS, Raastad T, Courneya KS, Skovlund E, Fossa 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.
Results Reference
derived

Learn more about this trial

The Physical Exercise and Prostate Cancer Study

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