Exercise for Breast Cancer Patients (EXCAP)

Fatigue Clinical Trial

Official title:

Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851812
• Other study ID #: 8029NCI
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

Behavioral:
• Exercise
Standard care monitoring
• Progressive walking and resistance exercise treatment
Home-based exercise : Progressive walking and resistance program

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center, University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related fatigue		4.5 months
Secondary	To provide preliminary data on influence of QOL and it's relationship to CRF		4.5 months