Exercise for Prostate Cancer Patients - Full Text View

Exercise for Prostate Cancer Patients (EXCAP)

This study is currently recruiting participants.

Verified November 2011 by University of Rochester

First Received on December 29, 2008. Last Updated on November 30, 2011 History of Changes

Sponsor:	University of Rochester
Collaborator:	Department of Defense
Information provided by (Responsible Party):	University of Rochester
ClinicalTrials.gov Identifier:	NCT00815672

Purpose

The purpose of this study is to gain a better understanding of the mechanisms responsible for cancer-related fatigue.

Condition	Intervention
Prostate Cancer Related Fatigue	Behavioral: Exercise

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care
Official Title:	The Influence of Home-based Aerobic and Resistance Exercise on Cancer-Related Fatigue, Strength, and Muscle Mass in Prostate Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Fatigue Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Cancer-related fatigue [ Time Frame: 4.5 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide preliminary data on influence of home-based aerobic and resistance exercise on strength, skeletal muscle mass, inflammatory response, QOL and it's relationship to CRF [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	122
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Treatment Arm 1 Usual Care: Standard care monitoring
Experimental: Treatment arm 2 Home-based Exercise: Progressive walking and resistance exercise treatment.	Behavioral: Exercise Progressive walking and resistance exercise treatment

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a primary diagnosis of prostate cancer
Have a KPS of 60 or greater.
Be receiving any form of treatment for their prostate cancer or have received some form of treatment (e.g. surgery, chemotherapy, radiation therapy, hormone therapy) in the last 10 years
Have approval of physician and be able to read English.
Be 21 years of age or older and give informed consent

Exclusion Criteria:

Have bone metastases that preclude participation due to symptoms such as pain or location of the bone metastasis.
Have physical limitations that contraindicate participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815672

Contacts

Contact: Karen Mustian, Ph.D.

585-273-1796

karen_mustian@urmc.rochester.edu

Locations

United States, New York
James P. Wilmot Cancer Center, University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Ann Colasurdo 585-276-4059 ann_colasurdo@urmc.rochester.edu
Principal Investigator: Karen Mustian, Ph.D.

Sponsors and Collaborators

University of Rochester

Department of Defense

Investigators

Principal Investigator:

Karen Mustian, Ph.D.

James P. Wilmot Cancer Center, University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00815672 History of Changes
Other Study ID Numbers:	1703DOD
Study First Received:	December 29, 2008
Last Updated:	November 30, 2011
Health Authority:	United States:Department of Defense

Keywords provided by University of Rochester:

Exercise
Prostate cancer
Fatigue

Additional relevant MeSH terms:

Fatigue
Prostatic Neoplasms
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012