Clinical Trial

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated March 27, 2026 (before its estimated July 12, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2017-05-05; most recent amendment 2026-03-24.
Status change: Recruiting → Active, Not Recruiting 2026-03-24
Status change: Not Yet Recruiting → Recruiting 2017-10-31
Trial Details
NCT Number NCT03144206
Lead Sponsor Duke University
Conditions Sarcoma, Hyperbaric Oxygen Therapy
Enrollment 20 participants
Start Date 2017-10-19
Primary Completion 2026-07-12 (estimated)
Study Completion 2026-07-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-27