Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study (NCT03144206) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study
United States20 participantsStarted 2017-10-19
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Any tumor grade
✓. Any histologic subtype
Exclusion criteria
✕. 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)