The Physical Exercise and Prostate Cancer Study

NCT00658229 | Completed Phase 3 DMC

• 1 other identifier: REK - 08/212b
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Exercise; Prostatic; Neoplasm; Androgen; Deprivation

Outcome Measures

Primary Outcomes (1)

• lean body mass

  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)

  before ADT, before and after the intervention

Study Arms (2)

Strength training group

EXPERIMENTAL

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

Behavioral: Strength training group

Control group

NO INTERVENTION

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.

Interventions

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).

Also known as: Exercise, Physical activity

Strength training group

Eligibility Criteria

• Age: Up to 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Rikshospitalet- Radiumhospitalet HF

Montebello, Oslo County, 0310, Norway

Location

Related Publications (1)

• 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.

  PMID: 22458865 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lene Thorsen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

NO (1)