Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study
Randomized Pilot Study Evaluating Hyperbaric Oxygen Therapy Following Management of Soft Tissue Sarcoma With Neo-adjuvant Radiation and Surgical Resection
Duke University
20 participants
Oct 19, 2017
INTERVENTIONAL
Conditions
Summary
A parallel-group randomized pilot trial at a single institution (Duke University) on the effect of postoperative hyperbaric oxygen therapy on wound healing in patients with soft tissue sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.. Participants will be allocated to either the treatment group (HBOT) or control (standard of care) by computer-generated randomization, stratified by tumor size (≤10cm and \>10cm). An unequal randomization of 2:1 will be utilized to provide experience prescribing HBOT to more patients.
Eligibility
Inclusion Criteria13
- Males and females within the ages of 18-85
- Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- Sarcoma of lower extremity location
- Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- 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 decreased perfusion of the extremity
- No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- Must be able to comply with follow up visits
- Must be able to provide own consent
Exclusion Criteria14
- Patients under the age of 18, or over the age of 85.
- Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
- Sarcoma location other than lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as \>5mg prednisone, or equivalent, daily)
- Active treatment with chemotherapy
- Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- Plan for post operative radiation therapy
- Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- 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)
- Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus with A1c\>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 serum pregnancy test prior to enrollment)
Interventions
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03144206