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Oxygen therapy tested to speed healing after sarcoma surgery

NCT ID NCT03144206

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study looks at whether hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) can help wounds heal better after surgery and radiation for soft tissue sarcoma. About 20 adults with sarcoma in the leg will be randomly assigned to receive either the oxygen therapy or standard care. The main goal is to see if this approach is practical and acceptable to patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2017

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 273710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.