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Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Primary Purpose

Sarcoma, Hyperbaric Oxygen Therapy

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric oxygen

About this trial

This is an interventional treatment trial for Sarcoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 DM 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)

Sites / Locations

Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyperbaric Oxygen Group

Standard of Care Group

Arm Description

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

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

Outcomes

Primary Outcome Measures

Recruitment rate

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

Hyperbaric Treatment Completion Rate

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

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.

Participant Assessment Form Completion Rate

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

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.

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

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03144206

First Posted

May 3, 2017

Last Updated

July 7, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03144206

Brief Title

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 19, 2017 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Hyperbaric Oxygen Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperbaric Oxygen Group

Arm Type

Experimental

Arm Description

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

Arm Title

Standard of Care Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen

Intervention Description

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

Primary Outcome Measure Information:

Title

Recruitment rate

Description

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

Time Frame

Screening

Title

Hyperbaric Treatment Completion Rate

Description

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

Time Frame

24 weeks postoperatively

Title

Wound Assessment Form Completion Rate

Description

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

Time Frame

24 weeks postoperatively

Title

Participant Assessment Form Completion Rate

Description

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

Time Frame

24 weeks postoperatively

Title

patient reported study strengths and weaknesses

Description

Time Frame

24 weeks postoperatively

Title

barriers to compliance with study procedures

Description

Time Frame

24 weeks postoperatively

Secondary Outcome Measure Information:

Title

Frequency of surgical site infections or periprosthetic infections

Description

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.

Time Frame

24 weeks postoperatively

Title

frequency of wound complications that result in a secondary procedure

Description

Time Frame

24 weeks postoperatively

Title

Wound Severity

Description

Variability in clinical evaluations of wound severity will be determined by the Bates-Jensen Wound Assessment score recorded in the Wound Assessment Form.

Time Frame

24 weeks postoperatively

Title

Frequency of delayed wound healing

Description

Time Frame

24 weeks postoperatively

Title

Variability in Patient Reported Quality of Life

Description

Time Frame

24 weeks postoperatively

Title

Variability in Patient Reported Wound Assessments

Description

Time Frame

24 weeks postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth J Sachs, MS

Phone

919-660-9849

elizabeth.sachs@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Eward, MD, DVM

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

273710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth J Sachs, MS

Phone

919-660-9849

elizabeth.sachs@duke.edu

First Name & Middle Initial & Last Name & Degree

William Eward, MD, DVM

12. IPD Sharing Statement

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Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

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