NCT03144206CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 3 May 2017
- Start date
- 19 Oct 2017
- Primary completion date
- 9 Sept 2026
- Lead sponsor
- Duke University
- Diseases
- Sarcoma
- NCT number
- NCT03144206
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 20
- From 19 Oct 2017 to the primary completion date, 9 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
- 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
- Plan for post operative radiation therapy
- Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
Other illness
- Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- 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
Lab values
- Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Age
- Patients under the age of 18, or over the age of 85.
Other
- Sarcoma location other than lower extremity
- Inability to comply with follow up visits
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.