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Hyperbaric Oxygen Therapy for Sarcoma
Phase 4
Recruiting
Led By William Eward, MD, DVM
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of soft tissue sarcoma confirmed by an approved reference pathologist
Sarcoma of lower extremity location
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks postoperatively
Awards & highlights
Study Summary
This trial will determine if postoperative hyperbaric oxygen therapy improves wound healing in patients with soft tissue sarcoma undergoing surgery and neo-adjuvant radiation therapy.
Who is the study for?
Adults aged 18-85 with soft tissue sarcoma in the lower extremity, who will have surgery after neo-adjuvant radiation therapy. Participants must not have had prior radiation in the area, be on high dose steroids or chemotherapy, have uncontrolled diabetes, active deep vein thrombosis, or compromised blood flow to the limb.Check my eligibility
What is being tested?
The study is testing if hyperbaric oxygen therapy (HBOT) improves wound healing post-surgery for soft tissue sarcoma patients compared to standard care. Patients are randomly placed into two groups: more will receive HBOT and fewer will get standard care.See study design
What are the potential side effects?
Possible side effects of HBOT include ear pain due to pressure changes, temporary vision changes, fatigue, and rarely lung collapse or seizures from too much oxygen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My soft tissue sarcoma diagnosis has been confirmed by a specialist.
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My sarcoma is located in my leg.
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I am scheduled for radiation therapy before surgery to remove my tumor.
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My surgery wound is expected to be closed primarily.
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My blood flow in limbs hasn't been reduced by surgery.
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I haven't had radiation or surgery on the tumor area before now.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hyperbaric Treatment Completion Rate
Participant Assessment Form Completion Rate
Recruitment rate
+3 moreSecondary outcome measures
Frequency of delayed wound healing
Frequency of surgical site infections or periprosthetic infections
Variability in Patient Reported Quality of Life
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hyperbaric Oxygen GroupExperimental Treatment1 Intervention
Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period
Group II: Standard of Care GroupActive Control1 Intervention
Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric oxygen
2013
Completed Phase 4
~280
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,466 Total Patients Enrolled
8 Trials studying Sarcoma
499 Patients Enrolled for Sarcoma
William Eward, MD, DVMPrincipal InvestigatorDuke Health
2 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Sarcoma
50 Patients Enrolled for Sarcoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 85 years old.My treatment plan includes radiation before surgery.My surgery wound is expected to be closed primarily.My surgery wound is expected to be closed primarily.My cancer can be of any stage, grade, or type.My blood flow in limbs hasn't been reduced by surgery.I have had radiation or surgery on the tumor area before this treatment.I am taking more than 5mg of prednisone or its equivalent daily.I have had surgery on a limb that affected its blood flow.My blood flow to the limb getting treatment is poor due to vascular disease.I haven't had radiation or surgery on the tumor area before now.I am younger than 18 or older than 85.My treatment plan does not include pre-surgery radiation or surgery to remove the tumor.My sarcoma is not located in my lower extremity.I am scheduled for radiation therapy after surgery.My diabetes is not well-controlled (A1c>8).My cancer can be of any severity.I am currently receiving chemotherapy.I have an active blood clot in the limb being treated.My soft tissue sarcoma diagnosis has been confirmed by a specialist.My sarcoma is located in my leg.I am scheduled for radiation therapy before surgery to remove my tumor.My blood flow in my limbs is normal and hasn't been affected by surgery.My soft tissue sarcoma diagnosis has been confirmed by a specialist.My cancer can be of any tissue type.My condition is at any stage of disease.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperbaric Oxygen Group
- Group 2: Standard of Care Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned Hyperbaric oxygen therapy?
"Hyperbaric oxygen has been approved and is thus assigned a score of 3, reflecting its established safety profile."
Answered by AI
Is my participation possible in this research endeavor?
"This clinical trial is seeking 20 qualified participants between the ages of 18-85 for hyperbaric oxygen therapy. To be included, one must have a histologically confirmed soft tissue sarcoma in the lower extremity which requires neo-adjuvant radiation followed by surgical resection with primary wound closure at time of surgery; any disease stage, tumor grade or subtype is acceptable including recurrent presentations so long as there are no vascular invasions that decrease perfusion to the extremity."
Answered by AI
Is this medical trial actively recruiting new participants?
"Data posted on clinicaltrials.gov suggests that enrollment is open for this study, which was first announced back in October 2017 and last updated December 2021."
Answered by AI
Is the age eligibility for this trial limited or can persons over 40 years old participate?
"Eligible participants are those aged 18 or above and no greater than 85."
Answered by AI
What is the maximum capacity for participants in this medical trial?
"Affirmative. Clinicaltrials.gov has the most recent information that this medical trial, which opened on October 19th 2017, is actively enrolling 20 individuals from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Vermont
How old are they?
18 - 65
What site did they apply to?
DUke University
What portion of applicants met pre-screening criteria?
Met criteria
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