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โ† Trials
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Exercise and Soft Tissue Sarcoma

RecruitingNAAges 18 Years - 85 YearsAllDuke University
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Males and females within the ages of 18-85 2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist 3. Sarcoma of the upper or lower extremity location 4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection 5. Expected primary wound closure performed at the time at surgery 6. Any disease stage 7. Any tumor grade 8. Any histologic subtype 9. First or recurrent presentations 10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 12. Must be able to comply with follow up visits 13. Must be able to provide own consent Exclusion Criteria: 1. Patients under the age of 18, or over the age of 85 2. Treatment plan that does not include neo-adjuvant radiation and surgical excision 3. Sarcoma location other than the upper or lower extremity 4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 5. High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days) 6. Active treatment with chemotherapy within the last 30 days 7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers) 8. Plan for post-operative radiation therapy 9. Underlying severe cardiopulmonary disease 10. Prior surgery, other than a biopsy, at the site of disease 11. Tumors that are ulcerative or fungating through the dermis at the time of presentation 12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 13. Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion) 14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c\>8) 15. Active deep vein thrombosis in the treatment extremity 16. Inability to comply with follow up visits 17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
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What it tests

  • neoadjuvant exercise therapy
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Where

1 site
Duke University
Durham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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