Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Hyperbaric Oxygen Therapy
• Intervention / Treatment: Drug: Hyperbaric oxygen

Detailed 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elizabeth J Sachs, MS; Phone Number: 919-660-9849; Email: elizabeth.sachs@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 273710
      • Recruiting
      • Duke University
      • Contact: Elizabeth J Sachs, MS; Phone Number: 919-660-9849; Email: elizabeth.sachs@duke.edu
      • Principal Investigator: William Eward, MD, DVM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females within the ages of 18-85
2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
3. Sarcoma of lower extremity location
4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
5. Expected primary wound closure performed at the time at surgery
6. Any disease stage
7. Any tumor grade
8. Any histologic subtype
9. First or recurrent presentations
10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
12. Must be able to comply with follow up visits
13. Must be able to provide own consent

Exclusion Criteria:

1. Patients under the age of 18, or over the age of 85.
2. Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
3. Sarcoma location other than lower extremity
4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
5. High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)
6. Active treatment with chemotherapy
7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
8. Plan for post operative radiation therapy
9. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
10. 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)
11. Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus with A1c>8)
12. Active deep vein thrombosis in the treatment extremity
13. Inability to comply with follow up visits
14. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric Oxygen Group; Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period	Drug: Hyperbaric oxygen; Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
No Intervention: Standard of Care Group; Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of surgical site infections or periprosthetic infections	the number of participants with ≥ 1 completed Wound Assessment Form documenting infection or treatment for infection around the wound area at any follow-up visit.	24 weeks postoperatively
frequency of wound complications that result in a secondary procedure	the number of participants with ≥ 1 completed Wound Assessment Form that documents reoperation or any other invasive procedure after primary resection with any wound complication as the indication for the procedure.	24 weeks postoperatively
Wound Severity	Variability in clinical evaluations of wound severity will be determined by the Bates-Jensen Wound Assessment score recorded in the Wound Assessment Form.	24 weeks postoperatively
Frequency of delayed wound healing	The frequency of delayed wound healing will be determined by the number of participants with of ≥ 1 completed Wound Assessment Form documenting ≥ 1 clinical indication of a wound complication at any follow-up visit.	24 weeks postoperatively
Variability in Patient Reported Quality of Life	Variability in patient reported outcome data pertaining to quality of life will be determined by the ESAS-SM score alone at baseline and by the ESAS-SM and WOUND-Q: Life Impact scores recorded in the Participant Assessment Form at all follow-up visits.	24 weeks postoperatively
Variability in Patient Reported Wound Assessments	Variability in patient reported outcome data pertaining to wound assessments will be determined by the WOUND-Q: Wound Characterization score recorded in the Participant Assessment Form at all follow-up visits.	24 weeks postoperatively

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: William Eward, MD, DVM, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: Pro00065596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No