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Exercise for Prostate Cancer Patients (EXCAP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815672
First Posted: December 30, 2008
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Karen Mustian, University of Rochester
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Karen Mustian, University of Rochester:

Primary Outcome Measures:
  • Cancer-related fatigue [ Time Frame: 4.5 Months ]

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 ]

Estimated Enrollment: 122
Study Start Date: December 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
United States Department of Defense
Investigators
Principal Investigator: Karen Mustian, Ph.D. James P. Wilmot Cancer Center, University of Rochester
  More Information

Responsible Party: Karen Mustian, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00815672     History of Changes
Other Study ID Numbers: 1703DOD
First Submitted: December 29, 2008
First Posted: December 30, 2008
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Karen Mustian, University of Rochester:
Exercise
Prostate cancer
Fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms