Know Cancer

forgot password

Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer

Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer

- 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Jennifer Ligibel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • metastatic breast cancer
  • exercise intervention
  • Breast Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Beth Isreal Deaconess Medical Center Boston, Massachusetts  02215