Hyperbaric Oxygen Therapy for Leukemia Engraftment

(HBO-UBC Trial)

Overseen By Kaitlyn Burrows

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Disqualifiers: Pregnant, COPD, Pneumothorax, Seizures, others

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: 6

Duration: 1 day

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether hyperbaric oxygen therapy can enhance the success of umbilical cord blood (UCB) transplants for blood cancers. UCB transplants hold promise due to their easier availability and lower risks compared to other transplant types. The trial compares two groups: those receiving hyperbaric oxygen therapy and those not receiving it. It seeks participants who need a stem cell transplant but lack a matching donor and have conditions like acute leukemia or lymphoma that have responded to some treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that hyperbaric oxygen therapy is likely to be safe for humans?

Research has shown that hyperbaric oxygen therapy (HBO) is generally safe for patients. Studies have found that using HBO therapy before an umbilical cord blood transplant does not cause serious side effects. Previous research has also highlighted its long-term safety. Minor side effects, such as ear pain from pressure changes, anxiety, or changes in vision, can occur but are uncommon. Overall, past studies have demonstrated that patients tolerate HBO therapy well, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for leukemia, which often involve chemotherapy and radiation, hyperbaric oxygen therapy (HBO) offers a unique approach by using increased atmospheric pressure to enhance oxygen delivery throughout the body. This method may accelerate the engraftment process, where transplanted stem cells begin to grow and produce healthy blood cells more effectively. Researchers are excited because HBO could improve recovery times and reduce complications associated with traditional treatments, offering a potentially faster and less invasive option for patients.

What evidence suggests that hyperbaric oxygen therapy might be an effective treatment for leukemia?

Research has shown that hyperbaric oxygen (HBO) therapy might improve outcomes for patients receiving umbilical cord blood (UCB) transplants for leukemia. In this trial, participants in the HBO arm will undergo HBO therapy before the UCB transplant. Initial studies have linked this approach to better outcomes 100 days after the procedure. This suggests that HBO can aid the growth of new stem cells and the production of healthy blood cells. Although some risks exist with the treatment, the chance of complications remains low. These findings offer hope that HBO could enhance recovery in UCB transplants. ^{3 6 7 8 9}

Who Is on the Research Team?

Omar Aljitawi

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

Minimum criteria include: ALT, AST: < 4x IULN, Total bilirubin: ≤ 2.0 mg/dL, Creatinine: ≤ 1.5 x ULN, EF measured by 2D-ECHO or MUGA scan of ≥ 45%, FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin), EKG with no clinically significant arrhythmia, Patients should have New York Heart Association (NYHA) Functional Classification, class -1 or class II, Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen, Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen, Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days following completion of therapy

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).

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric oxygen

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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 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 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 (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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9431014/

P1590: OUTCOME OF HYPERBARIC OXYGEN THERAPY ... Forty-four patients were evaluable for response of their infection to HBO treatment: 52% had improvement, 6% had stable infection, and 41% failed to respond.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265021017341

AML-410: Efficacy of Hyperbaric Oxygen Therapy in ... A small subset of patients with hematologic malignancies, 16% in our study, had meaningful recovery from infection after HBO treatment.

3. asco.org asco.org/abstracts-presentations/ABSTRACT169220

A pilot study using hyperbaric oxygen therapy to improve ... In a pilot clinical trial, we have demonstrated that hyperbaric oxygen (HBO) therapy prior to UCB transplantation was associated with improved day +100 outcomes ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03739502

A Randomized Phase II Study of Hyperbaric Oxygen in ... This research study is aimed at investigating the use of hyperbaric oxygen (HBO) therapy prior to the UCB transplant to find out if it will improve the stem ...

5. withpower.com withpower.com/trial/phase-3-myelodysplastic-syndromes-1-2019-076e9

Hyperbaric Oxygen Therapy for Leukemia Engraftment Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30382305/

Long-term results of a pilot study evaluating hyperbaric ... Our study highlights the long-term safety of HBO therapy when used prior to UCB transplantation. Future UCB transplant patients who receive HBO ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03964506

Hyperbaric Oxygen Therapy and Allogeneic Peripheral ... The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine ...

8. nature.com nature.com/articles/s41598-024-74858-8

Hyperbaric oxygen therapy in the treatment of late-onset ... Our data are consistent with the results of the four retrospective studies, reporting a complete response rate ranging from 57 to 94% (Table 5).

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02099266

Use of Hyperbaric Oxygen Therapy to Improve Umbilical ... If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process; The safety of HBO ...