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Brief Title: Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer
Official Title: Pre-Surgical Supervised Exercise for Bone Cancer Patients
Study ID: NCT02893397
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 5 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Name: Valerae O Lewis
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR