Exercise Intervention in Women With Metastatic Breast Cancer

NCT00405782 | Completed DMC

• 1 other identifier: 06-212
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

metastatic breast cancer; exercise intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (2)

• 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

  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.

  16 weeks

Study Arms (2)

Immediate Exercise Group

ACTIVE COMPARATOR

Exercise Intervention begins immediately

Behavioral: Moderate-Intensity Exercise

Delayed Exercise Group

ACTIVE COMPARATOR

Exercise intervention delayed by 16 weeks

Behavioral: Moderate-Intensity Exercise

Interventions

Moderate-Intensity Exercise BEHAVIORAL

Exercise program designed by exercise physiologist

Delayed Exercise Group; Immediate Exercise Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Baseline exercise of more than 150 minutes/week
• Active brain metastases
• Uncontrolled cardiac disease

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2016
• Last Updated: June 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)