RecruitingPhase 4NCT03144206

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

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

Sponsor

Duke University

Enrollment

20 participants

Start Date

Oct 19, 2017

Study Type

INTERVENTIONAL

Conditions

Sarcoma Hyperbaric Oxygen Therapy

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.. 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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) can help wounds heal better after surgery for soft tissue sarcoma of the leg. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with soft tissue sarcoma in your lower limb (confirmed by a specialist pathologist) - Your treatment plan includes radiation therapy before surgery, followed by surgical removal of the tumor with planned wound closure - Any disease stage, tumor grade, or tumor type is acceptable **You may NOT be eligible if...** - Your tumor is not located in the lower limb - You have blood vessel problems in the affected area that could complicate healing - You have conditions that make hyperbaric oxygen therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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