Exercise Intervention in Women With Metastatic Breast Cancer
June 24, 2016 updated by: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer
This study is being done to evaluate the impact of moderate-intensity exercise (such as walking) on quality of life, energy level, endurance and mood in women with metastatic breast cancer.
Studies have shown that women with early stage breast cancer who exercise during treatment have more energy, less sleep disturbance, less anxiety and depression, and better strength and endurance than women who do not exercise.
These studies have also shown that women who exercised during treatment for early stage breast cancer did not develop injuries or increased fatigue from exercising during chemotherapy and radiation treatments.
The investigators are conducting this trial to see if women with metastatic breast cancer experience similar benefits from exercise as women with earlier breast cancer.
The investigators also wish to determine whether women with advanced disease are able to exercise safely during their treatment under the supervision of an exercise physiologist.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Participants will be randomized to one of two groups. Study participants assigned to Group A will immediately participate in a 16-week exercise program, and participants assigned to Group B will wait 16 weeks before taking part in an exercise program.
- Before beginning the exercise program (Group A) or waiting period (Group B), participants will undergo a series of tests to measure exercise capacity, fatigue level and quality of life. They will be asked to complete a series of questionnaires and meet with an exercise physiologist and undergo a treadmill test designed to measure physical fitness in patients with a chronic illness. The participant will complete the questionnaires again 8 weeks after enrolling in the protocol and will complete one final set and undergo a second treadmill test after the 16-week study period has ended.
- Participants in Group A will be given a 16-week gym membership, as well as a heart rate monitor and a pedometer. They will meet with an exercise physiologist, who will design an exercise program for each participant. Participants will meet with the exercise physiologist weekly for 4 weeks, then once per month for the duration of the study. The target exercise goal will be 150 minutes of moderate-intensity exercise each week.
- Participants will be given an exercise journal to record the minutes of cardiovascular exercise and steps taken each day. These journals will be reviewed by the exercise physiologist each week.
- Participants in Group B will be allowed to exercise as much as they wish during the first 16-weeks of their time on the study, but they will not be given a formal exercise plan or a gym membership until the completion of the 16-week waiting period. During this time, they will also complete questionnaires at the time of study entry, 8 weeks after enrolling, and at the end of 16 weeks. After the 16-week delay period has passed, participants in Group B will be given a pedometer, heart rate monitor and 16-week gym membership. They will also meet with an exercise physiologist weekly for one month, and the exercise physiologist will design an individualized exercise plan for these participants.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Beth Isreal Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Metastatic or locally advanced breast cancer not amenable to curative surgery
- Life expectance of greater than 12 months
- English speaking
- Pre- and postmenopausal
- Performance status 0-1
Exclusion Criteria:
- Baseline exercise of more than 150 minutes/week
- Active brain metastases
- Uncontrolled cardiac disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Immediate Exercise Group
Exercise Intervention begins immediately
|
Exercise program designed by exercise physiologist
|
|
Active Comparator: Delayed Exercise Group
Exercise intervention delayed by 16 weeks
|
Exercise program designed by exercise physiologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the impact of a 16 week exercise intervention on physical functioning and cardiorespiratory fitness in a group of patients with metastatic breast cancer.
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the impact of a 16-week exercise intervention on quality of life, fatigue and mood in a group of patients with metastatic breast cancer
Time Frame: 16 weeks
|
16 weeks
|
|
To test the feasibility of an exploratory measure of health care utilization in a population of patients with metastatic breast cancer and potential impact on a 16-week exercise intervention on health care utilization.
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
November 28, 2006
First Submitted That Met QC Criteria
November 28, 2006
First Posted (Estimate)
November 30, 2006
Study Record Updates
Last Update Posted (Estimate)
June 27, 2016
Last Update Submitted That Met QC Criteria
June 24, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.