Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperbaric Oxygen Therapy | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperbaric oxygen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperbaric Oxygen Group
- description
- Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period
- interventionNames
- Drug: Hyperbaric oxygen
- type
- NO_INTERVENTION
- label
- Standard of Care Group
- description
- Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period
Primary outcomes (6)
- measure
- Recruitment rate
- timeFrame
- Screening
- description
- The proportion of eligible patients who enroll in this study, as indicated by the screening log.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available