Exercise Intervention in Women With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00405782
First received: November 28, 2006
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Moderate-Intensity Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Exercise Group
Exercise Intervention begins immediately
Behavioral: Moderate-Intensity Exercise
Exercise program designed by exercise physiologist
Active Comparator: Delayed Exercise Group
Exercise intervention delayed by 16 weeks
Behavioral: Moderate-Intensity Exercise
Exercise program designed by exercise physiologist

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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405782

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00405782     History of Changes
Other Study ID Numbers: 06-212
Study First Received: November 28, 2006
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
metastatic breast cancer
exercise intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014