Pre-Surgical Supervised Exercise for Bone Cancer Patients



Status:Recruiting
Healthy:No
Age Range:5 - 38
Updated:4/17/2018
Start Date:August 2016
End Date:August 2021
Contact:Valerae O. Lewis, MD, BS
Phone:713-745-4117

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The goal of this clinical research study is to learn if regular exercise is possible for
children and young adults with bone cancer who are having chemotherapy.

Study Groups:

If you agree to take part in this study, you will be assigned to 1 of 2 groups based on your
availability and if you live within 25 miles of MD Anderson:

- If you are in Group 1, you will take part in a supervised exercise program.

- If you are in Group 2, you will not take part in the exercise program.

Length of Study Participation No matter which group you are in, your participation in this
study will be over after you complete your chemotherapy and before surgery.

Study Visits:

For All Participants:

At the Beginning of the Study:

- You will have an MRI to check the status of the disease.

- You will have a physical test. Depending on your health, you will have a 6-minute walk
test or a 6-minute arm test. If you will do the 6-minute walk test, you will be timed
for 6 minutes to see how far you can walk on a course that is set up near or in the
clinic. If you will do the 6-minute arm test, you will exercise your arms for 6 minutes
using an upper body ergometer (UBE) which is much like pedaling a bike.

After your First Round of Chemotherapy:

°You will have the same physical test as before.

After 5-6 Weeks into Chemotherapy:

°You will have an MRI to check the status of the disease.

Right Before Surgery:

- You will have an MRI to check the status of the disease.

- You will have the same physical test as before.

For Group 1 Only:

You will be asked to exercise with a physical therapist at least 3 times a week throughout
your chemotherapy (10-12 weeks). You will be offered the chance to exercise up to 5 times a
week. You will take part in each exercise session for 40 minutes unless you are unable to
complete it. What you will do at each session will be based on your abilities and the
physical therapist may give you a few physical tests to see what is best for you.

During each session, you will use either a stationary bicycle or a UBE for up to 20 minutes.

Following a brief rest break, you will be asked to perform 10 minutes of upper and/or lower
body stretching and strengthening exercises.

Finally, you will have 10 minutes of an activity based exercise session, such as using a
Nintendo Wii, dribbling a basketball, shooting a basketball into a hoop, a bean bag toss, or
other light physical activities.

You or the physical therapist may stop the exercises at any time if you have severe pain or
symptoms.

While you are exercising, you will wear a small device called a portal pulse oximeter. This
will measure your blood pressure, your heart rate, and how much oxygen is in your blood. You
will also be asked questions about any pain you may be having and how tired you are. It
should take about 10-15 minutes to complete the questionnaire.

For Group 2 Only:

You will be asked to keep a log of your weekly activity, including how often you were active
and for how long. Physical activity includes any activity that works your muscles and
requires more energy than resting (such as house chores, walking, biking, and outdoor play).

This is an investigational study.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients must be equal to or greater than 5 years of age and less than 39 years of age
at the time of enrollment

2. Patients must have a new diagnosis of Osteosarcoma or Ewing's sarcoma of bone.

3. Both male and female patients are eligible

4. Patients who are receiving neoadjuvant chemotherapy treatment at UT MD Anderson Cancer
Center.

Exclusion Criteria:

1. Patients who are not receiving their primary cancer care and chemotherapy at MD
Anderson Cancer Center

2. Patients who have a cognitive disorder which impacts the ability to follow directions
or adhere to safety rules. This will be determined by the physical therapist by
assessing whether a neurological disorder or musculoskeletal disorder would prevent
the patient from safely exercising.

3. Patients who have a neurological or structural disorder which would impact use of
exercise equipment. This will be determined by the physical therapist by assessing
whether a neurological disorder or musculoskeletal disorder would prevent the patient
from safely exercising.

4. Any patient who, in the opinion of the investigators, will be unable to comply with a
supervised exercise regimen based on their developmental stage

5. Any concurrent co-morbid illness and/or infection which in the opinion of the
investigators could make the patient an inappropriate subject for the above trial
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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