Hyperbaric Oxygen Therapy for Sarcoma

Recruiting at 1 trial location

Overseen By Elizabeth J Sachs, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Chemotherapy, High-dose steroids

Disqualifiers: Age, Diabetes, Vascular disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hyperbaric oxygen therapy (breathing pure oxygen in a pressurized room) can improve wound healing after surgery in individuals with soft tissue sarcoma in the leg area. Participants will be randomly assigned to one of two groups: one receiving oxygen therapy and the other receiving standard care without it. The trial aims to determine if this additional oxygen can accelerate recovery post-surgery. It seeks individuals with soft tissue sarcoma in the lower body who plan to undergo surgery and have not received radiation treatment in that area before. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on high dose steroid therapy or active chemotherapy.

What is the safety track record for Hyperbaric Oxygen Therapy?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally safe for individuals with solid tumors, such as sarcoma. In studies where patients used HBOT for cancer-related issues, no serious or life-threatening side effects occurred. For example, among 2,692 HBOT sessions administered to 259 patients, only two mild side effects were reported, accounting for just 0.07% of sessions.

Moreover, HBOT has been shown to enhance wound healing, particularly after radiation treatment and surgery. This is significant for sarcoma patients who often undergo these procedures. Overall, HBOT appears well-tolerated, with a very low risk of side effects, making it a promising option for aiding recovery and healing. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about hyperbaric oxygen therapy for sarcoma because it offers a novel approach by utilizing pressurized oxygen to potentially enhance healing in the postoperative period. Unlike standard treatments such as surgery, chemotherapy, and radiation, which focus directly on tumor removal or destruction, hyperbaric oxygen therapy aims to improve tissue repair and reduce complications after surgery. This method floods the body with high levels of oxygen, which can speed up recovery and improve outcomes, making it a promising adjunct to existing sarcoma treatment options.

What evidence suggests that hyperbaric oxygen therapy is effective for wound healing in soft tissue sarcoma patients?

Research has shown that hyperbaric oxygen therapy (HBOT) can help manage issues in patients with solid tumors, such as sarcomas. Studies have found that HBOT improves tissue damage caused by radiation, which is common in sarcoma treatments. This therapy boosts oxygen levels in tumor tissues, aiding healing and reducing postoperative complications. In this trial, participants in the Hyperbaric Oxygen Group will receive HBOT immediately after surgery, while the Standard of Care Group will not. Additionally, combining HBOT with chemotherapy can lower the risk of cancer spreading to the lungs more effectively than chemotherapy alone. Overall, HBOT appears to be a promising option for aiding recovery and reducing complications in cancer patients. ^{2 6 7 8 9}

Who Is on the Research Team?

William Eward, MD, DVM

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My surgery wound is expected to be closed primarily.

My cancer can be of any stage, grade, or type.

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

Exclusion Criteria

Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neo-adjuvant Radiation

Participants receive pre-operative radiation treatment per standard of care

Varies

Surgical Resection

Participants undergo surgical excision as planned and performed by a surgical oncologist

Immediate post-radiation

Hyperbaric Oxygen Therapy

Participants randomized to the treatment group receive 7-10 HBO treatments within 7-10 days of surgery

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3, 6, 12, and 24 weeks postoperatively

24 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric oxygen

Trial Overview 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.

How Is the Trial Designed?

Group I: Hyperbaric Oxygen Group Experimental Treatment 1 Intervention

Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period

Group II: Standard of Care Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A systematic review of two randomized controlled trials on hyperbaric oxygen therapy (HBOT) for thermal burns found insufficient evidence to support its effectiveness, as the trials had poor methodological quality.

One trial indicated that HBOT may reduce healing times (19.7 days vs. 43.8 days), but the other showed no significant differences in length of hospital stay, mortality, or surgeries, highlighting the need for further research to clarify HBOT's role in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. Villanueva, E., Bennett, MH., Wasiak, J., et al.[2022]

This systematic review found no clinical trials that provide evidence for the effectiveness of hyperbaric oxygen therapy (HBOT) in treating necrotizing fasciitis, indicating a lack of data on its potential benefits.

The authors emphasize the need for high-quality clinical trials to determine whether HBOT can play a role in managing necrotizing fasciitis, as current evidence is insufficient to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive hyperbaric oxygen for necrotizing fasciitis. Levett, D., Bennett, MH., Millar, I.[2022]

A survey of 101 specialists (61 vascular surgeons and 40 podiatrists) revealed that only 37 used hyperbaric oxygen therapy (HBOT) for lower limb ulcers, with less than 8% believing it frequently has a role in treatment.

Most specialists agreed that a large clinical trial is necessary to better understand the efficacy of HBOT for treating lower limb ulcers, indicating a need for more robust evidence in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opinions of vascular surgeons and podiatrists in Australia and New Zealand on the use of hyperbaric oxygen therapy for lower limb ulcers. Drovandi, A., Fernando, ME., Singh, TP., et al.[2022]

In a study of 30 sarcoma patients treated with hyperbaric oxygen therapy (HBOT) from 2006 to 2017, 68.8% of those with chronic wounds experienced improved healing, indicating HBOT's efficacy in this area.

For patients suffering from late radiation tissue injury (LRTI), 75% reported reduced pain and 62.5% showed a decrease in fibrosis, suggesting that HBOT is both safe and beneficial for managing complications after sarcoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for radiation-induced tissue injury following sarcoma treatment: A retrospective analysis of a Dutch cohort. Generaal, JD., Lansdorp, CA., Boonstra, O., et al.[2020]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

Hyperbaric oxygen therapy (HBOT) significantly improves wound healing in patients with osteoradionecrosis (ORN) at stages 1 and 2, based on a retrospective study of 84 patients conducted over six years.

Patients with stage 2 ORN required the highest number of HBOT sessions for effective healing, while stage 3 patients benefited from bone debridement combined with fewer HBOT dives, indicating a tailored approach may be necessary for different ORN stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Adjunctive Hyperbaric Oxygen Therapy in Osteoradionecrosis. Jenwitheesuk, K., Mahakkanukrauh, A., Punjaruk, W., et al.[2020]

Hyperbaric oxygen therapy, which involves breathing 100% oxygen under high pressure, significantly increases the amount of oxygen available for cellular metabolism, leading to various beneficial effects that support healing in conditions like clostridial myonecrosis and chronic wounds.

While hyperbaric oxygen is now recognized as an effective adjunctive treatment for several medical conditions, further randomized controlled trials are needed to fully establish its efficacy and optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. Mutschler, W., Muth, CM.[2019]

In a study involving 14 patients with delayed radiation injuries from gynecological cancers, hyperbaric oxygen therapy (HBOT) showed a success rate of 71%, with 10 patients healing or improving by more than 50% after at least 20 sessions.

The treatment was well-tolerated, with acceptable adverse events, suggesting that HBOT is a promising option for patients who do not respond to other treatments for delayed radiation injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for delayed radiation injuries in gynecological cancers. Fink, D., Chetty, N., Lehm, JP., et al.[2018]

Hyperbaric oxygen therapy (HBOT) involves patients breathing 100% oxygen in a pressurized chamber, which enhances oxygen delivery to tissues and promotes cellular regeneration, making it a non-invasive and pain-free treatment option.

The therapy has been used since the 1960s for various medical conditions, and its efficacy is supported by evidence-based guidelines from the European Underwater and Baromedical Society, as demonstrated in three case studies where HBOT significantly aided treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in outpatient care]. Szolnoki, N., Gasztonyi, B., Paizs, T., et al.[2023]

A study of 155 patients undergoing hyperbaric oxygen (HBO₂) therapy revealed that there is a measurable increase in blood pressure (systolic, diastolic, and mean arterial pressure) following treatment, although the increase is not large.

Patients taking calcium channel blockers and beta-blockers experienced greater increases in blood pressure, while those on ACE inhibitors had a protective effect, suggesting that medication type can influence blood pressure responses during HBO₂ therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. Heyboer Rd, M., Wojcik, SM., Smith, G., et al.[2019]

In a study of 931 patients undergoing hyperbaric oxygen therapy, the overall incidence of oxygen toxicity seizures was found to be low, occurring in 1 in 2,121 treatments, or five per 10,000 treatments.

The risk of seizures significantly increased with higher treatment pressures, with zero seizures at 2.0 atmospheres, 15 per 10,000 at 2.4/2.5 atmospheres, and 51 per 10,000 at 2.8 atmospheres, indicating that treatment pressure should be carefully considered against potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure incidence by treatment pressure in patients undergoing hyperbaric oxygen therapy. Heyboer, M., Jennings, S., Grant, WD., et al.[2015]

In a pilot study of 24 patients with ST-elevation myocardial infarction (STEMI), hyperbaric oxygen therapy (HBOT) showed a significant improvement in heart perfusion and left ventricular ejection fraction compared to the control group after primary percutaneous coronary intervention (PPCI).

The HBOT group experienced a notable reduction in the number of affected SPECT segments from 47.1% to 33.7% at 6 weeks, indicating better heart function, while the control group showed less improvement, suggesting that HBOT may enhance recovery in ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Therapy Following Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction. Martín-Hernández, P., Gutiérrez-Leonard, H., Quintana, AR., et al.[2021]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

In a study of 23 oncological patients undergoing hyperbaric oxygen therapy (HBOT) for radiotherapy complications, it was found that HBOT may reduce bone remodeling activity, as indicated by a 6% decrease in the serum levels of the bone formation marker P1NP after treatment.

Patients with neoplasms exhibited higher baseline bone turnover compared to those with chronic anal fissures, suggesting that HBOT could be beneficial in managing increased bone remodeling in cancer patients post-radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of hyperbaric oxygen therapy on bone metabolism in patients with neoplasm. Salmón-González, Z., Anchuelo, J., Borregán, JC., et al.[2022]

In a study of 1005 breast cancer patients treated with hyperbaric oxygen therapy (HBOT), significant reductions in pain and symptoms related to breast and arm issues were observed, with pain scores decreasing from 43.4 to 29.7 after 3 months (p < 0.001).

Quality of life improved across all domains after HBOT, although the most common side effects were mild, such as myopia (57.3%) and barotrauma (17.8%), with only 3.2% of patients experiencing moderate to severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients. Batenburg, MCT., Maarse, W., van der Leij, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943617/

Hyperbaric Oxygen Therapy for Managing Cancer Treatment ... Conclusions: HBOT appears to be a safe and effective adjunctive therapy for managing complications in patients with solid tumors. No evidence ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7279578/

Hyperbaric oxygen therapy for radiation-induced tissue ... This study aims to gain insight in the use and results of hyperbaric oxygen therapy (HBOT) for radiation-induced complications following sarcoma treatment.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522302733370

Hyperbaric oxygen as a chemotherapy adjuvant in the ... Hyperbaric oxygen plus doxorubicin also significantly decreased the number of lung metastases and the lung weight relative to doxorubicin alone (P <.01 and P <.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1580515/full

Exploring a new direction in targeted cancer therapy ... The results showed that HBOT effectively increased the oxygen concentration in tumor tissues. Compared to a 60% tumor suppression rate with chemotherapy alone, ...

5. uhms.org uhms.org/images/MEDFAQs/Medical-Patient_Care/Daruwalla_hyperbaric_oxygen_and_cancer.pdf

Hyperbaric Oxygen Therapy for Malignancy: A Review One way to increase tumor oxygen tensions is by hyperbaric oxygen (HBO) therapy. HBO therapy can influence the tumor microenvironment at ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40142196/

Hyperbaric Oxygen Therapy for Managing Cancer ... Conclusions: HBOT appears to be a safe and effective adjunctive therapy for managing complications in patients with solid tumors. No evidence ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0234419

Hyperbaric oxygen therapy for radiation-induced tissue injury ... Conclusions. HBOT is safe and beneficial for treating chronic wounds and LRTI in the sarcoma population. Awaiting further prospective results, ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2017-01378

Hyperbaric Oxygen Therapy in Improving Wound Healing ... Giving hyperbaric oxygen therapy after radiation treatment and surgery may help improve wound healing in patients with soft tissue sarcoma.

9. journals.lww.com journals.lww.com/md-journal/fulltext/2025/10100/hematological_safety_of_hyperbaric_oxygen_therapy.29.aspx

Hematological safety of hyperbaric oxygen therapy in... Among 259 patients undergoing 2692 HBOT sessions, 2 mild treatment-emergent adverse events occurred (0.07%); no serious or life-threatening ...