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Hyperbaric Oxygen Therapy for Sarcoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Hyperbaric Oxygen Group
- Group 2: Standard of Care Group
- 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.
- 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
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."
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."
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."
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."
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."
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