Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Launched by DUKE UNIVERSITY · May 5, 2017

Keywords

ClinConnect Summary

This clinical trial, called the Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study, is exploring whether hyperbaric oxygen therapy (HBOT) can help improve wound healing for patients with soft tissue sarcoma after surgery. Specifically, the study is looking at patients who have had radiation treatment before their surgery. Participants will be randomly assigned to either receive HBOT or just the usual care after their surgery. The trial is being conducted at Duke University and is currently recruiting patients aged 18 to 85 who have been diagnosed with soft tissue sarcoma located in the lower part of their body.

To be eligible for this study, patients must be able to undergo surgery with expected wound closure and have no previous radiation treatment in the area being studied. It's important that participants can attend follow-up visits and provide their own consent. If you or a loved one meets these criteria, you might consider participating in this study, as it could help advance our understanding of how to support healing after surgery for 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 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 doesn't include neo-adjuvant radiation and surgical excision
• • 3. Sarcoma location other than 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, daily)
• • 6. Active treatment with chemotherapy
• • 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. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
• • 10. 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)
• • 11. Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus with A1c\>8)
• • 12. Active deep vein thrombosis in the treatment extremity
• • 13. Inability to comply with follow up visits
• • 14. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)