Hyperbaric Oxygen Therapy for Leukemia Engraftment

(HBO-UBC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Omar Aljitawi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Rochester

Disqualifiers: Pregnant, COPD, Pneumothorax, Seizures, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is hyperbaric oxygen therapy generally safe for humans?

Hyperbaric oxygen therapy is generally considered safe, but it can have side effects like ear pain due to pressure changes, anxiety, and changes in vision. Some people may also experience increased blood pressure or oxygen toxicity, which affects the lungs and nervous system. ^{1 2 3 4 5}

How does hyperbaric oxygen therapy differ from other treatments for leukemia engraftment?

Hyperbaric oxygen therapy is unique because it involves breathing pure oxygen in a pressurized chamber, which helps deliver more oxygen to tissues and can improve blood cell recovery after stem cell transplants. This approach is different from standard treatments as it enhances the body's ability to heal and recover by promoting better oxygenation and reducing complications like mucositis (painful inflammation and ulceration of the mucous membranes). ^{6 7 8 9 10}

Research Team

Omar Aljitawi

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for adults aged 18-70 with certain blood or lymph gland cancers needing a stem cell transplant but lacking matched donors. They must be in good physical condition, not pregnant, agree to use contraception, and have no severe lung/heart issues or recent surgeries that could complicate treatment.

Inclusion Criteria

A woman of child-bearing potential is any female who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months

I am over 45 or under 45 with a high HCT comorbidity index.

I am between 18 and 70 years old.

Exclusion Criteria

I have had a collapsed lung or significant lung scarring seen on scans within the last 2 months.

Pregnant or breastfeeding

You have a fear of enclosed spaces (claustrophobia).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive hyperbaric oxygen therapy to improve stem cell homing before UCB transplant

1 week

5 visits (in-person)

Treatment

Participants undergo umbilical cord blood stem cell transplantation

1 day

1 visit (in-person)

Engraftment Monitoring

Participants are monitored for stem cell engraftment and immune system recovery

4-6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Monthly visits (in-person)

Treatment Details

Interventions

• Hyperbaric oxygen (Other)

Trial Overview The study tests if hyperbaric oxygen therapy can improve the success of umbilical cord blood stem cell transplants in treating various cancers by reducing complications like graft versus host disease.

Participant Groups

Group I: HBO arm Experimental Treatment 1 Intervention

Group II: non-HBO arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

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]

Hyperbaric oxygen therapy (HBOT) has strong evidence supporting its use for treating radiation proctitis, with level A evidence, and moderate evidence for radiation cystitis and necrosis, with level B evidence.

The incidence of delayed radiation injuries in gynecologic cancer patients can be significant, reaching up to 23% in patients with cervical and vulvar cancers, highlighting the importance of HBOT in clinical practice for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. Allen, S., Kilian, C., Phelps, J., et al.[2022]

Hyperbaric oxygen therapy (HBOT) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

In a five-year study of 2,610 patients undergoing hyperbaric oxygen therapy (HBO2), 10.04% experienced middle ear barotrauma (MEB), highlighting it as a common side effect that can lead to premature treatment discontinuation.

Risk factors for MEB included being over 55 years old, female gender, and having a history of ear, nose, and throat issues, suggesting that identifying and managing these factors could help reduce the incidence of this adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients. Edinguele, WFOP., Barberon, B., Poussard, J., et al.[2021]

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]

Hyperbaric oxygen (HBO) treatment of umbilical cord blood (UCB) CD34+ cells reduces their proliferation, migration, and differentiation into erythrocytes, which could limit their effectiveness in treating hematological malignancies.

The study suggests that HBO increases reactive oxygen species (ROS) in the cells, which may be a mechanism behind the observed decrease in their functional capabilities, although it did not affect the expression of key receptors involved in cell homing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment effects on in vitro cultured umbilical cord blood CD34+ cells. Cheung, KY., Berry, A., Li, D., et al.[2019]

Hyperbaric oxygen therapy (HBO) showed a significant reduction in pain intensity for pediatric oncology patients with bone marrow edema (BME) and aseptic osteonecrosis (AON), particularly in younger girls, where pain scores decreased from an average of 2.4 to 0 during treatment.

While HBO therapy appeared to help reduce AON lesions in younger girls, it did not demonstrate a beneficial effect on BME in older children, indicating that the effectiveness of HBO may vary by age and type of lesion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow oedema and aseptic osteonecrosis in children and adolescents with acute lymphoblastic leukaemia or non-Hodgkin-lymphoma treated with hyperbaric-oxygen-therapy (HBO): an approach to cure? -- BME/AON and hyperbaric oxygen therapy as a treatment modality. Bernbeck, B., Christaras, A., Krauth, K., et al.[2019]

Hyperbaric oxygen (HBO) therapy is safe and well-tolerated in patients undergoing high-dose chemotherapy and autologous hematopoietic cell transplantation (auto-HCT), with a pilot study involving 20 patients showing promising results.

Patients receiving HBO experienced faster platelet recovery (16 days vs. 18 days in controls) and significantly lower rates of mucositis (26.3% vs. 64.2% in controls), suggesting HBO may enhance recovery and reduce complications associated with auto-HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the First Clinical Study in Humans That Combines Hyperbaric Oxygen Pretreatment with Autologous Peripheral Blood Stem Cell Transplantation. Abdelhakim, H., Shune, L., Bhatti, S., et al.[2020]

Hyperbaric oxygen (HBO) therapy enhances oxygen delivery to tissues, promoting healing and new blood vessel growth in areas with low oxygen, which is beneficial for treating conditions like radiation injuries and certain tumors.

Ongoing clinical studies in Europe are exploring HBO's role in increasing the effectiveness of radiation therapy for cancers, such as head and neck squamous cell carcinoma and glioblastoma, with protocols allowing for a short interval between HBO treatment and radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and radiotherapy. Mayer, R., Hamilton-Farrell, MR., van der Kleij, AJ., et al.[2007]

Hyperbaric oxygenation significantly reduced the proliferation rate and viability of promyelocytic leukemic HL60 cells compared to control groups, indicating a potential inhibitory effect on cell growth.

The treatment altered the expression of specific cell surface markers, with increases in CD11b, CD14, and CD16, suggesting that hyperbaric oxygen may influence cell differentiation and immune response in these leukemic cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of hyperbaric oxygenation on leukocyte viability and surface protein expression. McIntyre, KM., Dixon, PS., Krock, LP., et al.[2013]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]

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

Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients. [2021]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment effects on in vitro cultured umbilical cord blood CD34+ cells. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow oedema and aseptic osteonecrosis in children and adolescents with acute lymphoblastic leukaemia or non-Hodgkin-lymphoma treated with hyperbaric-oxygen-therapy (HBO): an approach to cure? -- BME/AON and hyperbaric oxygen therapy as a treatment modality. [2019]

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

Results of the First Clinical Study in Humans That Combines Hyperbaric Oxygen Pretreatment with Autologous Peripheral Blood Stem Cell Transplantation. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and radiotherapy. [2007]

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

The influence of hyperbaric oxygenation on leukocyte viability and surface protein expression. [2013]