Trial Information

Weight Gain Prevention for Breast Cancer Survivors

Women who are breast cancer patients having chemotherapy before surgery will be invited to
participate in the study. You will be allowed to participate in this study only if your
physician feels it is safe for you to participate in moderate physical activity, so you will
be asked to have him or her complete a form about your health conditions. Information about
the cancer and your treatment history will be obtained from your medical records as part of
the study.

If you agree to take part in this study, you will asked to come in for 2 visits at the
beginning of the study. At your first visit, your resting energy expenditure (REE) will be
measured. To test your REE, you will lie down on a bed while wearing a mask to measure the
air you let out when you breathe. You will have an electrocardiogram (ECG -- a test that
measures the electrical activity of the heart). Blood (about 2 teaspoons) will be drawn to
measure biomarkers, that may affect breast cancer. You will receive a packet of quality of
life questionnaires which will take 45 minutes to complete. You will also receive an
actigraph (a small, light-weight device that is worn on the waist during the day) that
provides researchers with information on your physical activity. You will be asked to wear
the actigraph for 7 days before your second visit. You will be given a diet questionnaire to
complete at home. The diet questionnaire will take 60 minutes to complete. You will be
asked to bring the actigraph and questionnaires to a baseline study visit.

At the second study visit you will also complete questionnaires about your physical
activity.

Your blood pressure and heart rate will be measured. Your physical fitness will be checked
by an exercise test done on a treadmill. The exercise test will be monitored by a qualified
health care provider and performed by a certified exercise specialist with training in
emergency procedures. The exercise intensity will begin at a low level and will be
increased over time. The test may be stopped at any time if you experience signs of fatigue
or changes in your heart rate, ECG, or blood pressure. You may also stop the test whenever
you wish.

Your height, weight, skinfolds, and hip and waist circumference will be measured. Your
arm, shoulder, and leg strength will be checked by asking you to stand on a platform and
grasp a bar connected to a strain gauge that measures force. Your hip and lower back
flexibility will checked using a 'sit and reach' method. Flexibility in your arm will be
checked using a goniometer, a small plastic measuring device similar to a ruler.

You will be given a packet of 10 collection tubes for collecting saliva samples with
instruction on collecting the samples over 2 days during the next week. You will also be
given a special mailer with which to return the samples. The second study visit will take
about 2 hours.

After your initial visit, you will be asked to come to M. D. Anderson to complete a Dual
energy x-ray absorptiometry (DEXA) scan to evaluate body composition.

At your baseline study visit, you will be randomly assigned (as in the toss of a coin) to
either a weight gain prevention group or a standard of care group. An equal number of
people will be assigned to each group.

If you are assigned to the intervention group, you will attend individual in-person study
visits at M. D. Anderson to receive instruction and counseling about exercise and diet.

While you are receiving chemotherapy, you will attend 1, 60-minute study visit per week for
16 weeks. During these visits, you will be given instructions on resistance and flexibility
exercises, using a pedometer (a small device that is worn during the day to give you
information about the number of steps you take), and making changes in your diet. You will
practice the exercises during this session, and receive feedback. Some of these session
might be video taped. You will be asked to give permission for the videotaping before the
session begins.

After the 16 weeks of in-person sessions, you will receive 1 telephone counseling session
per week for the remainder of the time you are on chemotherapy. Each telephone call will
take about 15-20 minutes. Some of these sessions might be tape-recorded. You will be asked
permission to tape-record the session before the telephone counseling session is begun. You
will receive written materials about making changes to your diet and exercise behavior. The
written materials will have information about overcoming barriers, rewarding yourself, and
time management. You will also receive hand weights, a step, and a stability ball for
exercising at home and a pedometer for monitoring your walking. The hand weights, step,
stability ball, and pedometer will be yours to keep. Based on the strength assessment,
tailored resistance exercises will be prescribed. You will do the exercises up to 3 times
per week. The exercise will target the major muscle groups.

After you have recovered from surgery, you will have 1 study visit a week for 3 weeks. You
will practice the exercises and again receive counseling to encourage you to exercise and to
eat according to your dietary recommendations. The exercises may be modified at this visit,
if necessary.

After these 3 weeks, you will receive 1 phone call a week for the next 6 weeks. Each
telephone call will take about 15-20 minutes. You will also receive additional written
materials that will include exercises and recommendations for maintaining the behavioral
changes made.

Regardless of which group you are in, you will be asked to come to M. D. Anderson for
follow-up assessments at the mid-point and end of chemotherapy, after recovering from
surgery, then 9 weeks and 6 months after surgery. You will be asked to come to M. D.
Anderson to complete a DEXA scan to evaluate body composition and bone mineral density at
the end of chemotherapy. For safety purposes, researchers will look for lymphedema at
follow-up evaluations after recovering from surgery, then 9 weeks and 6 months after
surgery. About 8 days before each follow-up visit we will send you a packet of seven
questionnaires that will take 45 minutes to complete, and an actigraph. You will be called
on the day you are supposed to wear the actigraph, and you will be given instructions about
completing the questionnaires. You will bring the questionnaires and actigraph to your
study visits. You will have the same tests and procedures at these study visits as you had
at the baseline visit.

You will be considered off-study 6 months after your surgery.

This is an investigational study. About 60 patients will take part in this study. All will
be enrolled at M. D. Anderson.