RECRUITING

Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2017-10-19

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03144206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Elizabeth J Sachs, MS

CONTACT

919-660-9849

elizabeth.sachs@duke.edu

Principal Investigator

William Eward, MD, DVM

PRINCIPAL_INVESTIGATOR

Duke Health

Study Locations (Sites)

Duke University

Durham, North Carolina, 273710

United States

Collaborators and Investigators

Sponsor: Duke University

William Eward, MD, DVM, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-19

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2017-10-19

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Sarcoma
Hyperbaric Oxygen Therapy