Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02893397
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Valerae O. Lewis, MD, BS
Phone 713-745-4117
Status Recruiting
Phase N/A
Start date August 2016
Completion date August 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03450122 - Study of Adoptive Immunotherapy Using Autologous CD8+ NY-ESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 For Patients With Sarcoma Phase 1
Recruiting NCT02464696 - Early Non Invasive Ventilation and Hematological Malignancies N/A
Recruiting NCT03291938 - Study to Evaluate the Safety and Tolerability of IACS-010759 in Subjects With Advanced Solid Tumors and Lymphoma Phase 1
Recruiting NCT03128866 - Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA) Early Phase 1
Recruiting NCT03430882 - TAK228 With Carbo and Taxol in Advanced Malignancies Phase 1
Withdrawn NCT02915172 - Lenvatinib and Capecitabine in Patients With Advanced Malignancies Phase 1
Recruiting NCT03420963 - Ex-Vivo Expanded Allogeneic NK Cells For The Treatment Of Pediatric Solid Tumors Phase 1
Recruiting NCT03217747 - Study to Evaluate the Safety and Tolerability of Avelumab in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies Phase 1/Phase 2
Recruiting NCT03449108 - Iovance Alliance: LN-145 Across Multiple Tumor Types Phase 2