Hyperbaric Oxygen Therapy for Sarcoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by William Eward, MD, DVM

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Duke University

Must not be taking: Chemotherapy, High-dose steroids

Disqualifiers: Age, Diabetes, Vascular disease, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Sarcoma?

Research shows that Hyperbaric Oxygen Therapy (HBOT) can improve wound healing in patients with osteoradionecrosis (a condition where bone tissue dies due to radiation), and it has been beneficial for treating delayed radiation injuries in gynecological cancers, with a success rate of 71% in one study. These findings suggest that HBOT may help in conditions involving tissue damage, which could be relevant for sarcoma treatment. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy is generally considered safe for humans, but it can have side effects like increased blood pressure, barotrauma (injury caused by pressure changes), seizures, anxiety, and visual disturbances. ^{6 7 8 9 10}

How does hyperbaric oxygen therapy differ from other treatments for sarcoma?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing 100% oxygen in a pressurized chamber, which increases oxygen levels in the body and promotes healing. Unlike traditional treatments for sarcoma, which may include surgery, chemotherapy, or radiation, HBOT is non-invasive and pain-free, offering a novel approach by enhancing tissue oxygenation and regeneration. ^{11 12 13 14 15}

Research Team

William Eward, MD, DVM

Principal Investigator

Duke Health

Eligibility Criteria

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

I am between 18 and 85 years old.

My surgery wound is expected to be closed primarily.

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• Hyperbaric oxygen (Other)

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.

Participant Groups

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+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

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]

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]

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]

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 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 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 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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Influence of hyperbaric oxygen therapy on bone metabolism in patients with neoplasm. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Adjunctive Hyperbaric Oxygen Therapy in Osteoradionecrosis. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for delayed radiation injuries in gynecological cancers. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for radiation-induced tissue injury following sarcoma treatment: A retrospective analysis of a Dutch cohort. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Seizure incidence by treatment pressure in patients undergoing hyperbaric oxygen therapy. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for thermal burns. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen Therapy Following Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Adjunctive hyperbaric oxygen for necrotizing fasciitis. [2022]

14. England 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. [2022]

15. Hungary pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in outpatient care]. [2023]