Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

March 24, 2026 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyperbaric Oxygen Group
Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period
Drug: Hyperbaric oxygen
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
No Intervention: Standard of Care Group
Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Screening
The proportion of eligible patients who enroll in this study, as indicated by the screening log.
Screening
Hyperbaric Treatment Completion Rate
Time Frame: 24 weeks postoperatively
The proportion of prescribed hyperbaric oxygen treatments that are completed, which will be recorded in the appointment log.
24 weeks postoperatively
Wound Assessment Form Completion Rate
Time Frame: 24 weeks postoperatively
The number of completed Wound Assessment Forms per participant divided by the total number of follow-up visits per participant.
24 weeks postoperatively
Participant Assessment Form Completion Rate
Time Frame: 24 weeks postoperatively
Number of completed Participant Assessment Forms per participant divided by the number of total follow-up visits per participant.
24 weeks postoperatively
patient reported study strengths and weaknesses
Time Frame: 24 weeks postoperatively
The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported study strengths and weaknesses.
24 weeks postoperatively
barriers to compliance with study procedures
Time Frame: 24 weeks postoperatively
The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported barriers to compliance with study procedures
24 weeks postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of surgical site infections or periprosthetic infections
Time Frame: 24 weeks postoperatively
the number of participants with ≥ 1 completed Wound Assessment Form documenting infection or treatment for infection around the wound area at any follow-up visit.
24 weeks postoperatively
frequency of wound complications that result in a secondary procedure
Time Frame: 24 weeks postoperatively
the number of participants with ≥ 1 completed Wound Assessment Form that documents reoperation or any other invasive procedure after primary resection with any wound complication as the indication for the procedure.
24 weeks postoperatively
Wound Severity
Time Frame: 24 weeks postoperatively
Variability in clinical evaluations of wound severity will be determined by the Bates-Jensen Wound Assessment score recorded in the Wound Assessment Form.
24 weeks postoperatively
Frequency of delayed wound healing
Time Frame: 24 weeks postoperatively
The frequency of delayed wound healing will be determined by the number of participants with of ≥ 1 completed Wound Assessment Form documenting ≥ 1 clinical indication of a wound complication at any follow-up visit.
24 weeks postoperatively
Variability in Patient Reported Quality of Life
Time Frame: 24 weeks postoperatively
Variability in patient reported outcome data pertaining to quality of life will be determined by the ESAS-SM score alone at baseline and by the ESAS-SM and WOUND-Q: Life Impact scores recorded in the Participant Assessment Form at all follow-up visits.
24 weeks postoperatively
Variability in Patient Reported Wound Assessments
Time Frame: 24 weeks postoperatively
Variability in patient reported outcome data pertaining to wound assessments will be determined by the WOUND-Q: Wound Characterization score recorded in the Participant Assessment Form at all follow-up visits.
24 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Eward, MD, DVM, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00065596

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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