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ACTIVE NOT RECRUITING
NCT03144206
PHASE4

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Sponsor: Duke University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2017-10-19

Completion Date

2026-07-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Hyperbaric oxygen

Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period

Locations (1)

Duke University

Durham, North Carolina, United States