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
  Purpose

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.


Condition Intervention
Fatigue
Behavioral: Exercise
Behavioral: Progressive walking and resistance exercise treatment

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: Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

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 QOL and it's relationship to CRF [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: May 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Usual Care: Standard care monitoring
Behavioral: Exercise
Standard care monitoring
Other Name: Usual care: standard care monitoring
Experimental: Arm 2
Progressive walking and resistance exercise treatment
Behavioral: Progressive walking and resistance exercise treatment
Home-based exercise : Progressive walking and resistance program

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851812

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: NCT00851812     History of Changes
Other Study ID Numbers: 8029NCI
Study First Received: February 24, 2009
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Exercise
Breast cancer
fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014