Exercise for Prostate Cancer Patients (EXCAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00815672
First received: December 29, 2008
Last updated: November 7, 2013
Last verified: November 2013
  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:


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 2014 (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
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 7, 2013
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 April 17, 2014