Phase
Condition
Sarcoma
Sarcoma (Pediatric)
Soft Tissue Sarcoma
Treatment
neoadjuvant exercise therapy
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females within the ages of 18-85
Diagnosis of soft tissue sarcoma that has been histologically confirmed by anapproved reference pathologist
Sarcoma of the upper or lower extremity location
Treatment plan that includes neo-adjuvant radiation therapy followed by surgicalresection
Expected primary wound closure performed at the time at surgery
Any disease stage
Any tumor grade
Any histologic subtype
First or recurrent presentations
No vascular invasion or resection/repair/reconstruction that results in decreasedperfusion of the extremity
No history of radiation therapy to the tumor and/or surgical area prior to thecurrent treatment being studied
Must be able to comply with follow up visits
Must be able to provide own consent
Exclusion
Exclusion Criteria:
Patients under the age of 18, or over the age of 85
Treatment plan that does not include neo-adjuvant radiation and surgical excision
Sarcoma location other than the upper or lower extremity
History of radiation therapy to the tumor and/or surgical area prior to the currenttreatment being studied
High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days)
Active treatment with chemotherapy within the last 30 days
Inability of the patient to provide informed consent (i.e. dementia, cognitiveimpairment, non-English speakers)
Plan for post-operative radiation therapy
Underlying severe cardiopulmonary disease
Prior surgery, other than a biopsy, at the site of disease
Tumors that are ulcerative or fungating through the dermis at the time ofpresentation
Vascular invasion or resection/repair/reconstruction that results in decreasedperfusion of the extremity
Vascular disease resulting in clinically apparent compromise in blood flow to thetreatment extremity (i.e. peripheral vascular disease with diminished pulses, venousinsufficiency with clinical evidence of vascular congestion)
Actively uncontrolled diabetes mellitus (documentation of history of Diabetes withA1c>8)
Active deep vein thrombosis in the treatment extremity
Inability to comply with follow up visits
Pregnant females (women of childbearing potential must have a negative serumpregnancy test prior to enrollment)
Study Design
Connect with a study center
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
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