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Exercise and Soft Tissue Sarcoma
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- neoadjuvant exercise therapy (other)
Sponsor: Duke University · Participants: 24 · Started: Apr 30, 2021
Contact the study team
- Elizabeth Sachs, MS · Phone: 919-660-9849
Official record on ClinicalTrials.gov — NCT04921917
Locations in the U.S.
| North Carolina | Duke University, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.