Hyperbaric oxygen therapy for healing in soft tissue sarcoma patients
Randomized Pilot Study Evaluating Hyperbaric Oxygen Therapy Following Management of Soft Tissue Sarcoma With Neo-adjuvant Radiation and Surgical Resection
This study is testing if hyperbaric oxygen therapy can help patients with soft tissue sarcoma heal better after surgery compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03144206 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the effects of postoperative hyperbaric oxygen therapy (HBOT) on wound healing in patients with soft tissue sarcoma of the lower extremities who have undergone surgical resection following neo-adjuvant radiation therapy. Participants will be randomly assigned to receive either HBOT or standard care, with a focus on those with varying tumor sizes. The study aims to evaluate the efficacy of HBOT in enhancing recovery and healing post-surgery through a structured follow-up over six months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with histologically confirmed soft tissue sarcoma of the lower extremities who are scheduled for neo-adjuvant radiation therapy followed by surgical resection.
Not a fit: Patients with sarcomas located outside the lower extremities or those not undergoing the specified treatment plan may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve wound healing outcomes for patients undergoing surgery for soft tissue sarcoma.
How similar studies have performed: While the use of hyperbaric oxygen therapy has been explored in various contexts, this specific application for soft tissue sarcoma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: William Eward, MD, DVM — Duke Health
- Study coordinator: Elizabeth J Sachs, MS
- Email: elizabeth.sachs@duke.edu
- Phone: 919-660-9849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.