Exercise in Women at Risk for Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

This 2-part study will examine how much exercise people usually do in the course of their daily lives and how two different types of exercise-stretching and walking-affect the amount of fat in the body and certain hormones in the blood. It will also examine whether exercise can be increased by physician counseling with and without the use of a pedometer, and if exercising changes levels of stress, anxiety, and depression. Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75 years of age and who exercise less than 3 times per week may be eligible for this study. Candidates are screened with a medical history and physical examination, and their endurance and flexibility are tested by stretching exercises and by a 6-minute walk or run. All participants complete study Part 1. Those who are eligible may also participate in Part 2. * Part 1: Subjects wear a pedometer (a small device that measures the number of steps taken) on their waistband during all waking hours for 1 week without changing their usual level of activity. Depending on their level of activity, subjects may be invited to participate in Part 2 of the study. * Part 2: Subjects are placed in either a walking group or a stretching group for 12 weeks. At the end of the 12-week period, those in the walking group are offered participation in the stretching group, and those in the stretching group are offered participation in the walking group. Walking group participants wear a pedometer every day for 12 weeks. They are asked to gradually increase the number of steps they take each day, to keep a record of their daily step count, and to report periodically to the study staff on their progress. For 1 week during the study, participants also wear a device called an accelerometer that is used to verify the accuracy of the pedometer step counts. Stretching group participants follow a program of stretching exercises for 12 weeks, with their progress monitored periodically by staff. During week 12, participants wear a pedometer and accelerometer. All Part 2 participants also have the following tests and procedures: * Blood draw: collected at the beginning and end of the study to test for certain hormones and HDL cholesterol levels. * Questionnaires: about stress, anxiety, and depression levels; these are completed at the beginning and end of the study, and a detailed questionnaire about diet is completed at home or during a clinic visit. * Body composition measurement: A "bioelectrical impedance" test, which measures body fat, is done at the beginning and end of the study. For this test, the subject lies on an examining table and a small electrical current is passed through electrodes placed on one hand and one foot. Although a small electrical current is used, this test is not painful. * Endurance and flexibility testing: At the end of the study, participants repeat the 6-minute walk or run endurance test and the stretching flexibility test performed at screening.

Key facts

Study ID

NCT00092950

Run by

National Cancer Institute (NCI)

People needed

88

Starts

2004-09-23

Expected to finish

2009-12-07

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Currently pregnant or planning to become pregnant during the study period. Pregnancy will be assessed in women of childbearing potential prior to enrolling in stage II of the study. Postmenopausal women and women who have had a previous hysterectomy, oophorectomy or tubal ligation will not be required to undergo a pregnancy test.
• Uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
• Physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
• Medical or psychiatric disorder which would, in the opinion of the Principal Investigator, render the subject unable to provide informed consent.
• Patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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