Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Description

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

Sarcoma, Hyperbaric Oxygen Therapy

Study Overview

Study Details

Study overview

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.

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

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Condition
Sarcoma
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 273710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

William Eward, MD, DVM, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

2026-12-31