Exercise Intervention in Women With Metastatic Breast Cancer

Status:	Archived
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

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.

- 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.

We found this trial at

sites

Beth Israel Deaconess Medical Center`

Boston, Massachusetts 02115

from

Boston, MA