SarcomaPhase 4NCT03144206
Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study
A Phase 4 study testing Hyperbaric oxygen in people with Sarcoma and Hyperbaric Oxygen Therapy, run by Duke University at 1 site in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcoma, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 9 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females within the ages of 18-85
- Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- Sarcoma of lower extremity location
- Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- Expected primary wound closure performed at the time at surgery
- Any disease stage
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- Any tumor grade
- Any histologic subtype
- First or recurrent presentations
- No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- Must be able to comply with follow up visits
- Must be able to provide own consent
Who cannot join
- Patients under the age of 18, or over the age of 85.
- Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
- Sarcoma location other than lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)
- Active treatment with chemotherapy
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- Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- Plan for post operative radiation therapy
- Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- 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)
- Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus with A1c>8)
- Active deep vein thrombosis in the treatment extremity
- Inability to comply with follow up visits
- Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Hyperbaric oxygen
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Group | Experimental | Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period Receives: Drug: Hyperbaric oxygen |
| Standard of Care Group | No intervention | Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The proportion of eligible patients who enroll in this study, as indicated by the screening log.
Measured: Screening
Hyperbaric Treatment Completion Rate
The proportion of prescribed hyperbaric oxygen treatments that are completed, which will be recorded in the appointment log.
Measured: 24 weeks postoperatively
Wound Assessment Form Completion Rate
The number of completed Wound Assessment Forms per participant divided by the total number of follow-up visits per participant.
Measured: 24 weeks postoperatively
Participant Assessment Form Completion Rate
Number of completed Participant Assessment Forms per participant divided by the number of total follow-up visits per participant.
Measured: 24 weeks postoperatively
patient reported study strengths and weaknesses
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.
Measured: 24 weeks postoperatively
barriers to compliance with study procedures
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
Measured: 24 weeks postoperatively
Secondary outcomes (6)
Frequency of surgical site infections or periprosthetic infections
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.
Measured: 24 weeks postoperatively
frequency of wound complications that result in a secondary procedure
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.
Measured: 24 weeks postoperatively
Wound Severity
Variability in clinical evaluations of wound severity will be determined by the Bates-Jensen Wound Assessment score recorded in the Wound Assessment Form.
Measured: 24 weeks postoperatively
Frequency of delayed wound healing
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.
Measured: 24 weeks postoperatively
Variability in Patient Reported Quality of Life
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.
Measured: 24 weeks postoperatively
Variability in Patient Reported Wound Assessments
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.
Measured: 24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start19 Oct 2017
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Eward, MD, DVM, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144206
- Sponsor's protocol ID
- Pro00065596
- Status last verified
- Oct 2026
- First submitted
- 3 May 2017
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study Evaluating Hyperbaric Oxygen Therapy Following Management of Soft Tissue Sarcoma With Neo-adjuvant Radiation and Surgical Resection
- ClinicalTrials.gov ID
- NCT03144206
- Acronym / sponsor ID
- Pro00065596
- Conditions
- Sarcoma, Hyperbaric Oxygen Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Group | Experimental | Drug: Hyperbaric oxygenPatients will receive Hyperbaric Oxygen treatments in the immediate postoperative period |
| Standard of Care Group | No intervention | –Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females within the ages of 18-85
- Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- Sarcoma of lower extremity location
- Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- Expected primary wound closure performed at the time at surgery
Key exclusion criteria (14 listed)
- Patients under the age of 18, or over the age of 85.
- Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
- Sarcoma location other than lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygenPatients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period | Drug | Hyperbaric Oxygen Group |
Primary outcome
Recruitment rate
Time frame: Screening
The proportion of eligible patients who enroll in this study, as indicated by the screening log.
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.
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.
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.
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.
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
6 secondary outcomes
Frequency of surgical site infections or periprosthetic infections
Time frame: 24 weeks postoperatively
frequency of wound complications that result in a secondary procedure
Time frame: 24 weeks postoperatively
Wound Severity
Time frame: 24 weeks postoperatively
Frequency of delayed wound healing
Time frame: 24 weeks postoperatively
Variability in Patient Reported Quality of Life
Time frame: 24 weeks postoperatively
Variability in Patient Reported Wound Assessments
Time frame: 24 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Eward, MD, DVM principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric oxygen in people with Sarcoma and Hyperbaric Oxygen Therapy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.