Exercise in Women at Risk for Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      Background:

      Evidence suggests that high levels of physical activity can decrease breast cancer risk.

      Physical activity could therefore represent a viable breast cancer prevention strategy.

      In order to study the effect of physical activity on breast cancer risk, we must first
      develop feasible and efficacious physical activity interventions.

      Objectives:

      Primary:

      To determine the rate of compliance with a physical activity intervention using a pedometer,
      a physician prescription, and a motivational booklet.

      To determine whether this intervention is more effective than a control of stretching
      exercises at increasing physical activity.

      Secondary:

      To determine whether physical activity as measured by a pedometer correlates with other
      measures of physical activity.

      To assess the effect of the physical activity intervention on serum biomarkers, quality of
      life, functional capacity and body composition.

      To examine long-term compliance with a program of increased physical activity and assess post
      program exercise motivation and adherence.

      Eligibility:

      Eligible patients are women age 18-75 who meet one of the following criteria:

      History of breast cancer without evidence of recurrent disease.

      Gail model 5 year risk greater than 1.7%.

      Claus model lifetime risk greater than 20%.

      History of appropriately treated DCIS.

      History of high risk lesion on breast biopsy (ADH, ALH, LCIS).

      Known or suspected BRCA1 or BRCA2 mutation.

      Patients must be sedentary at baseline and must be medically fit to exercise.

      Design:

      This is a randomized pilot study designed to assess the feasibility of a physical activity
      intervention in breast cancer survivors and women at high risk for breast cancer.

      Stage I: Patients undergo a baseline activity evaluation for one week which involves wearing
      a sealed pedometer - those that have an average daily step count of less than 5,000 steps are
      eligible for randomization.

      Stage II: Patients are assigned to either a walking intervention, (including a pedometer, a
      physician exercise prescription with a final goal of walking 10,000 steps per day, and a
      motivational booklet) or a control of stretching exercise for a period of 12 weeks.

      Biomarkers, functional capacity, body composition and diet are assessed at the beginning and
      end of study.

      This study plans to randomize 80 subjects, and has a greater than 90% power to detect a mean
      increase of 3,000 steps per day in intervention subjects.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: Exercise; Pedometer; Physician Prescription; Biomarkers; Compliance; Breast Cancer Survivor; Breast Cancer Risk