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Exercise for Breast Cancer Patients (EXCAP)

Primary Purpose

Fatigue

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Progressive walking and resistance exercise treatment

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Exercise, Breast cancer, fatigue

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

James P. Wilmot Cancer Center, University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Usual Care: Standard care monitoring

Progressive walking and resistance exercise treatment

Outcomes

Primary Outcome Measures

Cancer-related fatigue

Secondary Outcome Measures

To provide preliminary data on influence of QOL and it's relationship to CRF

Full Information

NCT ID

NCT00851812

First Posted

February 24, 2009

Last Updated

February 13, 2020

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00851812

Brief Title

Exercise for Breast Cancer Patients (EXCAP)

Official Title

Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

January 15, 2020 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Exercise, Breast cancer, fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Other

Arm Description

Usual Care: Standard care monitoring

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Progressive walking and resistance exercise treatment

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Other Intervention Name(s)

Usual care: standard care monitoring

Intervention Description

Standard care monitoring

Intervention Type

Behavioral

Intervention Name(s)

Progressive walking and resistance exercise treatment

Intervention Description

Home-based exercise : Progressive walking and resistance program

Primary Outcome Measure Information:

Title

Cancer-related fatigue

Time Frame

4.5 months

Secondary Outcome Measure Information:

Title

To provide preliminary data on influence of QOL and it's relationship to CRF

Time Frame

4.5 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Mustian, Ph.D.

Organizational Affiliation

James P. Wilmot Cancer Center, University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

James P. Wilmot Cancer Center, University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

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Exercise for Breast Cancer Patients (EXCAP)

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