🏛️ Verified NIH Record • Updated 2026-03-24

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study (NCT03144206)

Randomized Pilot Study Evaluating Hyperbaric Oxygen Therapy Following Management of Soft Tissue Sarcoma With Neo-adjuvant Radiation and Surgical Resection

🔵 Active, Not Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Duke University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (15 items).

Location: Duke University — Durham, North Carolina

Age range: 18 Years to 85 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Duke University — Durham, North Carolina

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: All participants will receive pre-operative radiation treatment per standard of care and will undergo surgical excision as planned and performed by one of the surgical oncologists at our center.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗