Hyperbaric Oxygen Therapy for Leukemia Engraftment
(HBO-UBC Trial)
Recruiting in Palo Alto (17 mi)
OA
Overseen byOmar 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?
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).678910
Research Team
OA
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.
See 12 more
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).
See 8 more
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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: HBO armExperimental Treatment1 Intervention
Group II: non-HBO armActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of RochesterRochester, NY
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Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Trials
883
Patients Recruited
555,000+
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]
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Hyperbaric oxygen and radiotherapy.Mayer, R., Hamilton-Farrell, MR., van der Kleij, AJ., et al.[2007]
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
The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]
The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. [2022]
Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]
Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients. [2021]
Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. [2019]
Hyperbaric oxygen treatment effects on in vitro cultured umbilical cord blood CD34+ cells. [2019]
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]
Results of the First Clinical Study in Humans That Combines Hyperbaric Oxygen Pretreatment with Autologous Peripheral Blood Stem Cell Transplantation. [2020]
Hyperbaric oxygen and radiotherapy. [2007]
The influence of hyperbaric oxygenation on leukocyte viability and surface protein expression. [2013]