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Exercise for Prostate Cancer Patients (EXCAP)
This study is currently recruiting participants.
Verified by University of Rochester, February 2009
First Received: December 29, 2008   Last Updated: February 25, 2009   History of Changes
Sponsor: University of Rochester
Collaborator: Department of Defense
Information provided by: 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: Supportive Care, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title: The Influence of Home-Based Aerobic and Resistance Exercise on Cancer-Related Fatigue, Strength, and Muscle Mass in Prostate Patients During Radiotherapy

Resource links provided by NLM:


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: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Arm 1: No Intervention
Usual Care: Standard care monitoring
Treatment arm 2: Experimental
Home-based Exercise: Progressive walking and resistance exercise treatment.
Behavioral: Exercise
Progressive walking and resistance exercise treatment

  Show Detailed Description

  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, with no distant metastasis or recurrent disease.
  • Have a KPS of 60 or greater.
  • Be scheduled for at least 28 total radiation treatments without concurrent chemotherapy or interferon treatments.
  • Have approval of physician and be able to read English.
  • Be 21 years of age or older and give informed consent

Exclusion Criteria:

  • Have had previous radiation for cancer treatment within the last 2 years.
  • Have metastatic disease or physical limitations.They also should not be identified as active or maintenance stage of exercise behavior.
  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    
Contact: Caitlin Maska     585-275-7091     caitlin_maska@urmc.rochester.edu    
Principal Investigator: Karen Mustian, Ph.D.            
Sponsors and Collaborators
University of Rochester
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 ( Karen Mustian Ph.D. )
Study ID Numbers: 1703DOD
Study First Received: December 29, 2008
Last Updated: February 25, 2009
ClinicalTrials.gov Identifier: NCT00815672     History of Changes
Health Authority: United States:Department of Defense

Keywords provided by University of Rochester:
Exercise
Prostate cancer
Fatigue

Additional relevant MeSH terms:
Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009