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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

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Bone and Articular Cartilage Behavioral: Supervised Exercise Program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-Surgical Supervised Exercise for Bone Cancer Patients
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supervised exercise program
Exercise with a physical therapist at least 3 times a week throughout chemotherapy (10-12 weeks)
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

No Intervention: No exercise program
No supervised exercise.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893397


Contacts
Contact: Valerae O. Lewis, MD, BS 713-745-4117
Contact: Orthopaedic Oncology 713-745-4117

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Valerae O. Lewis, MD, BS The University of Texas MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02893397     History of Changes
Other Study ID Numbers: 2016-0411
NCI-2016-01969 ( Registry Identifier: NCI CTRP )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms
Cartilage Diseases
Soft Tissue Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type