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Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

NCT03144206 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Hyperbaric Oxygen Therapy

Interventions

DRUG

Hyperbaric oxygen

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

Sponsors & Collaborators

Principal Investigators

  • William Eward, MD, DVM · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2026-07-12
Completion
2026-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144206 on ClinicalTrials.gov