The Physical Exercise and Prostate Cancer Study

Prostate Cancer Clinical Trial

— PEPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658229
• Other study ID #: REK - 08/212b
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2008
• Last updated: October 12, 2012
• Start date: November 2008
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Norway	Rikshospitalet- Radiumhospitalet HF	Montebello	Oslo

Sponsors (7)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass		before ADT, before and after the intervention	No
Secondary	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)		before ADT, before and after the intervention	No