Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Prostate Cancer Clinical Trial

Official title:

Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856102
• Other study ID #: H2008:318
• Status: Completed
• Phase: N/A
• First received: March 3, 2009
• Last updated: January 31, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• men aged 50 or older

• diagnosed with adenocarcinoma prostate cancer

• will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months

Exclusion Criteria:

• severe cardiac disease (New York Heart Association class III or greater)

• angina

• severe osteoporosis

• uncontrolled hypertension

• orthostastic blood pressure drop > 20mm Hg

• moderate to severe aortic stenosis

• acute illness or fever

• uncontrolled atrial or ventricular dysrhythmias

• uncontrolled sinus tachycardia (> 120 beats per minute)

• uncontrolled congestive heart failure

• third-degree atrio-ventricular heart block

• active pericarditis or myocarditis

• recent embolism, thrombophlebitis

• deep vein thrombosis, resting ST displacement

• uncontrolled diabetes

• uncontrolled pain

• cognitive impairment

• history of falls due to balance impairment or lost of consciousness

• severe neuromusculoskeletal conditions that limit their ability to perform walking exercise

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise
Home-base walking program
• Control
Usual care

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive-psychosocial functions		3 and 6 months	No
Secondary	health-related quality of life		3 and 6 months	No