Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

NCT ID: NCT03144206

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-19
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Patients with a primary diagnosis of soft tissue sarcoma of the lower extremities undergoing treatment with neo-adjuvant radiation therapy and surgical resection will be screened for eligibility. 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. Participants randomized to the treatment group will be scheduled for 7-10 HBO treatments within 7-10 days of surgery. All participants will be scheduled for follow-up visits with their surgical oncologist at the following post-operative time points: 3, 6, 12, and 24-weeks (+/- 14 days). Follow up for the purposes of this study will continue up to 6 months from the time of surgery.

Conditions

Sarcoma; Hyperbaric Oxygen Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyperbaric Oxygen Group

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

Group Type: EXPERIMENTAL

Hyperbaric oxygen

Intervention Type: DRUG

Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period

Standard of Care Group

Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric oxygen

Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Eward, MD, DVM

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth J Sachs, MS

Role: CONTACT

elizabeth.sachs@duke.edu

919-660-9849

Facility Contacts

Elizabeth J Sachs, MS

Role: primary

elizabeth.sachs@duke.edu

919-660-9849

Other Identifiers

Pro00065596

Identifier Type: -

Identifier Source: org_study_id