Houston, Texas 77030


Purpose:

This clinical trial studies how well supervised exercise works in improving physical fitness before surgery in patients with bone cancer that can be removed by surgery. Supervised exercise may provide better short-term physical fitness in patients with bone cancer.


Study summary:

PRIMARY OBJECTIVES: I. To determine if regular exercise, which may improve delivery and efficacy of chemotherapy, is feasible in children and young adults with malignant bone tumors undergoing neoadjuvant chemotherapy. SECONDARY OBJECTIVES: I. To determine if exercise results in a change in tumor vascularity as evidenced by magnetic resonance imaging (MRI) in children and young adults with malignant bone tumors who participate in structured aerobic exercise as compared to children and young adults who do not. II. To determine whether serum levels of thrombospondin-1, an endogenous anti-angiogenic protein, and sphingosine-1-phosphate, an angiogenic modulator, increase in children and young adults with malignant bone tumors who participate in supervised aerobic exercise over a 4 week period of time during neoadjuvant chemotherapy. III. To determine if aerobic exercise decreases reactive oxygen species (ROS) in the peripheral blood of bone sarcoma patients. IV. To determine if the numbers of circulating tumor cells decrease in patients who participate in supervised exercise over a 4 week period of time. V. To determine whether a home-based exercise program or supervised exercise program is more feasible for this patient population. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks. GROUP II: Patients wear a fitbit.


Criteria:

Inclusion Criteria: - Patients must have a new diagnosis of primary bone tumor, and whose treatment plan includes surgery - Patients who are expected to receive at least 4 weeks of neoadjuvant chemotherapy treatment between enrollment in the study and planned surgery - Participants willing to wear a Fitbit Exclusion Criteria: - Patients who are not receiving their primary cancer care (surgery and chemotherapy) at MD Anderson Cancer Center (participants from the supervised exercise group only) - 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 - 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 - Any patient who, in the opinion of the investigators, will be unable to comply with a supervised exercise regimen - Any concurrent co-morbid illness and/or infection which in the opinion of the investigators could make the patient unable to comply fully with the trial procedures


NCT ID:

NCT02893397


Primary Contact:

Principal Investigator
Valerae O Lewis
M.D. Anderson Cancer Center

Valerae O. Lewis, BS,MD
Phone: 713-745-4117
Email: volewis@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Valerae O. Lewis
Phone: 713-745-4117

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.