Exercise and Soft Tissue Sarcoma

Launched by DUKE UNIVERSITY · Jun 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how a special exercise program can help patients with soft tissue sarcoma before they undergo surgery. The main goal is to see if exercising before treatment can improve how well patients recover and heal after their surgery, especially for those with tumors in their arms or legs. The study involves people aged 18 to 85 who have a confirmed diagnosis of soft tissue sarcoma and are scheduled to receive radiation therapy followed by surgery.

To participate in this trial, individuals must be generally healthy, able to commit to follow-up visits, and not have certain medical conditions that could complicate their treatment. Participants will be asked to follow the exercise program alongside their usual treatment and will be monitored closely to see how it affects their recovery. This trial is currently recruiting patients, and it offers a potential opportunity to improve outcomes for those facing surgery for soft tissue sarcoma.

Gender

ALL

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)