Osteosarcoma Clinical Trial
Official title:
A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy
This application proposes a prospective clinical trial to evaluate the impact of adding a focused physical therapy (PT) intervention to the preoperative regimen of individuals diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Patient being treated at St. Jude Children's Research Hospital - Permission from participant's physician - Participants must be between the ages of 6 and 30 years of age - Patient is newly diagnosed with LE malignancy as shown by biopsy. Diagnoses include: osteosarcoma, Ewing's sarcoma, rhabdomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath sarcoma, malignant fibrous histiocytoma of the bone and chondrosarcoma of the bone, or any other LE malignancy that requires surgical intervention. - Patient has Karnofsky score = 50 or WHO/ECOG = 2 if = 16 years of age - Lansky score = 50 for patients age < 16 - Surgical intervention is planned primary mechanism of local control - Negative pregnancy test - All patients and/or their parents or legal guardians must sign a written informed consent Exclusion Criteria: - Patients with serious, non-healing wound, ulcer or bone fracture (other than pathologic fracture) - Pre-morbid condition that prevents patient from ambulating - Patients who do not have at least 10 weeks before receiving local control |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital | Tennessee Physical Therapy Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of a 10 week physical therapy intervention program | Determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen. We will consider the study to be feasible if at least 60% of the patients are able to complete at least 50% of their scheduled PT sessions. | Up to 12 weeks post surgery | No |
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