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Pre-Surgical Supervised Exercise for Bone Cancer Patients

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ClinicalTrials.gov Identifier: NCT02893397
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE September 8, 2016
Last Update Posted Date March 23, 2018
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
Percentage Participants Completing Daily Exercise [ Time Frame: 10 - 12 weeks ]
Percentage of participants completing represents Implementation feasibility of exercise for patients with bone cancer. Feasibility reached if at least 10 out of 15 patients in supervised exercise group complete more than or equal to 80% (24 sessions) supervised physical therapy exercise sessions over the course of 10 weeks. Completion of daily exercise is defined as at least 20 minutes of aerobic exercise achieved within heart rate (HR) and blood pressure (BP) that the licensed physical therapist has determined is safe for the patient on that given day.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02893397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-Surgical Supervised Exercise for Bone Cancer Patients
Official Title  ICMJE Pre-Surgical Supervised Exercise for Bone Cancer Patients
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Neoplasms of Bone and Articular Cartilage
Intervention  ICMJE Behavioral: Supervised Exercise Program
Assigned exercises with a physical therapist 3 - 5 times a week throughout chemotherapy (10-12 weeks), each exercise session lasting for 40 minutes
Study Arms  ICMJE
  • Active Comparator: Supervised exercise program
    Exercise with a physical therapist at least 3 times a week throughout chemotherapy (10-12 weeks)
    Intervention: Behavioral: Supervised Exercise Program
  • No Intervention: No exercise program
    No supervised exercise.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 38 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valerae O. Lewis, MD, BS 713-745-4117
Contact: Orthopaedic Oncology 713-745-4117
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02893397
Other Study ID Numbers  ICMJE 2016-0411
NCI-2016-01969 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valerae O. Lewis, MD, BS The University of Texas MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP