Text Size

Exercise for Prostate Cancer Patients (EXCAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00815672
First received: December 29, 2008
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
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:

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 Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (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

  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
  • 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

Locations
United States, New York
James P. Wilmot Cancer Center, University of Rochester
Rochester, New York, United States, 14642
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: October 3, 2012
Health Authority: United States: Federal Government

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 May 16, 2013