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Completed

NCT Number: NCT00658229

The Physical Exercise and Prostate Cancer Study

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Rikshospitalet- Radiumhospitalet HF

Montebello, Oslo, 0310, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength training group

Behavioral

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 names: Exercise, Physical activity

Primary outcomes

  1. lean body mass

    Time frame: before ADT, before and after the intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Foundation for Health and Rehabilitation
  • Norwegian School of Sport Sciences
  • The Royal Norwegian Ministry of Health
  • Ullevaal University Hospital
  • University of Alberta
  • University of Oslo

Registry information

Official study title

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

Acronym: PEPC

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2008
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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