What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as chemotherapy, radiation therapy, and hyperbaric oxygen therapy (HBOT), have various side effects. Chemotherapy drugs like etoposide, ifosfamide, and doxorubicin can cause nausea, vomiting, hair loss, fatigue, and increased infection risk due to bone marrow suppression. Radiation therapy may lead to skin irritation, fatigue, and long-term risks like secondary cancers. HBOT, which enhances wound healing, can cause ear and sinus pain, temporary vision changes, and, rarely, oxygen toxicity. Combining these treatments can amplify side effects, requiring careful management by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of sarcoma, including doxorubicin, which is often used in combination with other agents like olaratumab. Doxorubicin has also been studied in combination with hyperthermia to enhance its efficacy. Another approved drug is pazopanib, a tyrosine kinase inhibitor used for advanced soft tissue sarcoma. While hyperbaric oxygen therapy itself is not specifically approved for sarcoma treatment, it is being studied for its potential to enhance wound healing post-surgery in sarcoma patients.

What other types of research exist?

Promising novel alternatives to Hyperbaric Oxygen Therapy for sarcoma patients include low-level laser therapy (LLLT), which has shown potential in improving healing and symptoms, and autologous platelet concentrates (APC), which have been used to enhance wound healing in various surgical contexts. Medical ozone therapy is another option that has demonstrated benefits in small case series. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Hyperbaric Oxygen Therapy for Sarcoma

Phase 4

Recruiting

Led By William Eward, MD, DVM

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of soft tissue sarcoma confirmed by an approved reference pathologist

Sarcoma of lower extremity location

Must not have

Active treatment with chemotherapy

Actively uncontrolled diabetes mellitus (A1c>8)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks postoperatively

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if breathing pure oxygen in a pressurized room can help patients with leg sarcoma heal better after surgery and radiation. The extra oxygen might speed up their recovery. Hyperbaric oxygen therapy (HBOT) has been shown to have beneficial effects in the treatment of late radiation sequelae.

Who is the study for?

Adults aged 18-85 with soft tissue sarcoma in the lower extremity, who will have surgery after neo-adjuvant radiation therapy. Participants must not have had prior radiation in the area, be on high dose steroids or chemotherapy, have uncontrolled diabetes, active deep vein thrombosis, or compromised blood flow to the limb.

What is being tested?

The study is testing if hyperbaric oxygen therapy (HBOT) improves wound healing post-surgery for soft tissue sarcoma patients compared to standard care. Patients are randomly placed into two groups: more will receive HBOT and fewer will get standard care.

What are the potential side effects?

Possible side effects of HBOT include ear pain due to pressure changes, temporary vision changes, fatigue, and rarely lung collapse or seizures from too much oxygen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My soft tissue sarcoma diagnosis has been confirmed by a specialist.

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My sarcoma is located in my leg.

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I am scheduled for radiation therapy before surgery to remove my tumor.

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My surgery wound is expected to be closed primarily.

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My blood flow in limbs hasn't been reduced by surgery.

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I haven't had radiation or surgery on the tumor area before now.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving chemotherapy.

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My diabetes is not well-controlled (A1c>8).

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I have an active blood clot in the limb being treated.

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I have had radiation or surgery on the tumor area before this treatment.

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I am taking more than 5mg of prednisone or its equivalent daily.

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I have had surgery on a limb that affected its blood flow.

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My blood flow to the limb getting treatment is poor due to vascular disease.

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I am younger than 18 or older than 85.

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My treatment plan does not include pre-surgery radiation or surgery to remove the tumor.

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My sarcoma is not located in my lower extremity.

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I am scheduled for radiation therapy after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hyperbaric Treatment Completion Rate

Participant Assessment Form Completion Rate

Recruitment rate

+3 more

Secondary study objectives

Frequency of delayed wound healing

Frequency of surgical site infections or periprosthetic infections

Variability in Patient Reported Quality of Life

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hyperbaric Oxygen GroupExperimental Treatment1 Intervention

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

Group II: Standard of Care GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric oxygen

2013

Completed Phase 4

~360

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sarcoma include chemotherapy, radiation therapy, and hyperbaric oxygen therapy (HBOT). Chemotherapy targets and kills rapidly dividing cancer cells, which helps in shrinking tumors. Radiation therapy damages the DNA of cancer cells, leading to their death and reducing tumor size. HBOT increases oxygen availability in tissues, enhancing the effectiveness of radiation therapy and promoting better wound healing post-surgery. These mechanisms are vital for sarcoma patients as they improve surgical outcomes, reduce tumor burden, and potentially increase survival rates.

[Co-operation of fundamental research with clinical work in radiation oncology].Tumour oxygenation under normobaric and hyperbaric conditions.