Trial Information

The Effects of Combined Strength Training and Functional Endurance Exercise Regimen on Cancer-Related Fatigue and Physical Performance

Cancer-related fatigue has been described as the most common and troubling side effect of
cancer and cancer treatment. Researchers want to see if a strength-training and walking
exercise regimen may help reduce severe fatigue and increase patients' ability to perform
activities of daily living.

If you agree to take part in this study, you will complete a questionnaire, provide contact
information, and participate in 1 of 2 groups. For the questionnaire, you will be asked
information about your age, ethnic origin, marital status, education, exercise habits, and
cancer diagnosis. It should take about 5 minutes to complete. For the contact information,
you will be asked to provide the name, address, and telephone number of someone to call in
case of an emergency.

After completing the questionnaire and providing the contact information, you will be
randomly assigned (as in the toss of a coin) to 1 of 2 groups. Participants in the exercise
group will be taught to perform a specific regimen for strength-training and walking
exercises. Participants in the nonexercise group will follow the usual routines of standard
care but will not be taught to perform a specific regimen for strength-training and walking
exercises. Participants in the nonexercise group will be asked to keep a record of any
exercises that are done for the participant's personal regimen that are not a part of this
study. You will have an equal chance of being assigned to either group.

All participants in this study will be asked to complete questionnaires (the Schwartz
Fatigue Scale, Karnofsky Performance Scale, and the International Physical Activity
Questionnaire [IPAQ]) in the Breast Center Clinic before beginning chemotherapy treatment.
The Schwartz Fatigue Scale and IPAQ will also be completed after chemotherapy treatment. All
of these questionnaires will be used to provide information about your physical activities
and how much time you spend doing them. It should take about 25-30 minutes to complete all 3
questionnaires.

No matter what group you are in, after these questionnaires are completed, a physical
therapist will then escort you to the exercise room located in the Physical Therapy and
Rehabilitation Clinic. The therapist will perform a lymphedema (excess fluid collection)
evaluation that will involve measuring the size of your arms and hands by placing a tape
measure around your arms and hands at 5 different points. The lymphedema evaluation will be
done at each clinic visit when you come in for chemotherapy and 2 weeks after completing
your therapy. You will also be asked to complete exercise testing, the Estimated
Timed-Get-Up and Go test (ETGUPGo) and a 6-minute walk test, to check your level of fatigue
and physical ability. This exercise testing will be performed before you begin chemotherapy
and within 2 weeks after you finish your last chemotherapy treatment. The exercise testing
will be done after your chemotherapy treatment so that researchers can compare your level of
fatigue and physical performance to what you were experiencing before your therapy began.

The ETGUPGo test will measure how fast you can rise from a chair, walk about 4 yards,
turnaround and return to the chair, and sit down. For the 6-minute walk test the therapist
will ask you to walk around in the exercise room at your own pace while the therapist counts
the total time you were able to walk. Two (2) weeks after you have finished all of your
treatments, you will re-take the Schwartz Fatigue Scale, Karnofsky Scale, IPAQ, ETGUPGo, and
6-minute walk test. Your exercise testing will be done in private, which means that no one
other than the study staff will be allowed to enter the room while you are being tested.

If you are assigned to the group that will have a specific exercise regimen, you will be
taught a strengthening and walking exercise. For the strengthening regimen, you will be
taught to stretch a Theraband (material that looks like a big rubber band) as far as your
arms or legs can stretch. You will be taught to perform this exercise at home. You will be
able to look at pictures of these exercises in a booklet that will be provided to you. You
will be asked to perform these exercises 3-5 times per week. For the walking regimen, you
will be taught the proper posture for walking for exercise. You must walk at least once per
day, but otherwise you may walk as often and as long as you feel like.

You will also have exercise testing. The therapist will measure the length of your arms and
legs to see how much force it takes for you to stretch the rubber band beyond the length of
your arms and legs. The therapist will test your current muscle strength by asking you to
sit and rise from a chair, walk a certain distance, and return to the chair. You will also
be asked to walk a certain distance until you get tired. The therapist will record how much
time it takes you to complete both exercises (strengthening and walking).

After you begin the exercises at home, the research nurse will call you every 2 weeks and
ask you how many times you performed the strengthening exercises throughout the week as well
as the average amount of time you walked each day. The phone call should last about 10-15
minutes each time. You will be asked to check the box on an exercise calendar (that will be
provided to you) showing which exercises you were able to perform each day.

All exercise testing will be given on the day of your routine visits to the clinic.

Your participation will be complete in this study after you perform your last exercise
testing (about 2 weeks after your last chemotherapy treatment).

This is an investigational study. However, if you begin to experience some emotional
distress that is directly related to this study, you may be referred for professional
counseling here at M. D. Anderson in the Social Work Department. The social services staff
will be available to assist you with the referral outside of the M. D. Anderson system. Up
to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.