Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

NCT03144206 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00065596
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  The proportion of eligible patients who enroll in this study, as indicated by the screening log.

  Screening

• Hyperbaric Treatment Completion Rate

  The proportion of prescribed hyperbaric oxygen treatments that are completed, which will be recorded in the appointment log.

  24 weeks postoperatively

• Wound Assessment Form Completion Rate

  The number of completed Wound Assessment Forms per participant divided by the total number of follow-up visits per participant.

  24 weeks postoperatively

• Participant Assessment Form Completion Rate

  Number of completed Participant Assessment Forms per participant divided by the number of total follow-up visits per participant.

  24 weeks postoperatively

• patient reported study strengths and weaknesses

  The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported study strengths and weaknesses.

  24 weeks postoperatively

• barriers to compliance with study procedures

  The Patient Feedback Survey will be given to all participants at their final study-related visit in order to collect qualitative and quantitative data on patient reported barriers to compliance with study procedures

  24 weeks postoperatively

Secondary Outcomes (6)

• Frequency of surgical site infections or periprosthetic infections

  24 weeks postoperatively

• frequency of wound complications that result in a secondary procedure

  24 weeks postoperatively

• Wound Severity

  24 weeks postoperatively

• Frequency of delayed wound healing

  24 weeks postoperatively

• Variability in Patient Reported Quality of Life

  24 weeks postoperatively

Study Arms (2)

Hyperbaric Oxygen Group

EXPERIMENTAL

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

Drug: Hyperbaric oxygen

Standard of Care Group

NO INTERVENTION

Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period

Interventions

Hyperbaric oxygen DRUG

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

Hyperbaric Oxygen Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• First or recurrent presentations
• No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
• No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
• Must be able to comply with follow up visits
• Must be able to provide own consent

You may not qualify if:

• 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)
• Active treatment with chemotherapy
• Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
• Plan for post operative radiation therapy
• Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
• Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion)
• Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus with A1c\>8)
• Active deep vein thrombosis in the treatment extremity
• Inability to comply with follow up visits
• Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 273710, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• William Eward, MD, DVM

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 8, 2017
• Study Start: October 19, 2017
• Primary Completion (Estimated): July 12, 2026
• Study Completion (Estimated): July 12, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Locations

US (1)