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Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Sarcoma Clinical Trial

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

Clinical 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.. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03144206
Study type Interventional
Source Duke University
Contact Elizabeth J Sachs, MS
Phone 919-660-9849
Email elizabeth.sachs@duke.edu
Status Recruiting
Phase Phase 4
Start date October 19, 2017
Completion date December 31, 2026
View Details
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