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Exercise for Breast Cancer Patients (EXCAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00851812
First received: February 24, 2009
Last updated: November 7, 2013
Last verified: November 2013

February 24, 2009
November 7, 2013
May 2007
April 2015   (final data collection date for primary outcome measure)
Cancer-related fatigue [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851812 on ClinicalTrials.gov Archive Site
To provide preliminary data on influence of QOL and it's relationship to CRF [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise for Breast Cancer Patients (EXCAP)
Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

The purpose of this study is to examine if exercise helps improve cancer-related fatigue.

Hypothesis: A structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

Fatigue is a frequently reported side effect of cancer treatment. Fatigue related to cancer and its treatment is different from fatigue occurring in other situations and its specific causes have not been identified. Exercise may or may not improve this type of fatigue. The purpose of this study is to examine how cancer treatments impact normal lifestyle physical activity patterns and participation in physical activity, as well as the ability of a walking and progressive resistance exercise program to reduce cancer-related fatigue in breast cancer patients. This study also examines if the walking and progressive resistance exercise program improves other factors such as quality of life, depression, anxiety, ability to sleep, self esteem, cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and immune function (as measured by inflammatory cytokines).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Fatigue
  • Behavioral: Exercise
    Standard care monitoring
    Other Name: Usual care: standard care monitoring
  • Behavioral: Progressive walking and resistance exercise treatment
    Home-based exercise : Progressive walking and resistance program
  • Arm 1
    Usual Care: Standard care monitoring
    Intervention: Behavioral: Exercise
  • Experimental: Arm 2
    Progressive walking and resistance exercise treatment
    Intervention: Behavioral: Progressive walking and resistance exercise treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
114
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a primary diagnosis of breast cancer,
  • Have a functional capacity rating of 60 or greater on the Karnofsky Performance Scale, when assessed by the oncologist (or physician's designee)
  • Be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). Have a life expectancy of >1 year as determined by the patient's oncologist.
  • Have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program.
  • Be able to read English.
  • Be 21 years of age or older.
  • Give informed consent.

Exclusion Criteria:

  • Have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis.
  • Have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the PAR-Q and radiation oncologist (or physician's designee)
  • Be identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00851812
8029NCI
Yes
University of Rochester
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Karen Mustian, Ph.D. James P. Wilmot Cancer Center, University of Rochester
University of Rochester
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP