Hyperbaric Oxygen Therapy for Leukemia Engraftment
(HBO-UBC Trial)
Recruiting in Palo Alto (17 mi)
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
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 RochesterLead Sponsor
References
The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]Hyperbaric oxygen (HBO2) therapy is applied in a growing number of cases for patients with different comorbidities and is considered a generally safe therapy. The main side effects related to HBO2 therapy are barotrauma, central nervous system- and pulmonary oxygen toxicity, claustrophobia, anxiety and visual disturbances. The aim of this study was to evaluate the incidence of side effects associated with HBO2 therapy and risk factors in a large cohort of patients treated for different indications.
The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. [2022]The purposes of this paper are to review the best evidence supporting the use of hyperbaric oxygen therapy (HBOT) in delayed radiation injuries in gynecologic malignancies and report the incidence of radiation injuries at two large medical centers in southeastern Wisconsin.
Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]Hyperbaric oxygen therapy (HBOT) is one of the common clinical treatments, but adverse effects have hampered and limited the clinical application and promotion of hyperbaric oxygen therapy. A systematic review and meta-analysis of the adverse effects of hyperbaric oxygen therapy have conducted by our group to provide a theoretical basis for clinical treatment.
Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients. [2021]Hyperbaric oxygen (HBO2) therapy is the use of oxygen or gas mixtures at a pressure above atmospheric pressure for therapeutic purposes. This treatment is used in numerous pathological processes. Its main side effect is middle ear barotrauma (MEB), which represents a great concern for iatrogenic HBO2 therapy. The aim of this work is to describe this adverse event in order to highlight clinical elements that can contribute to its prevention and management.
Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. [2019]Hyperbaric oxygen (HBO₂) therapy is generally safe and well tolerated. However, known side effects do exist. Elevation in the blood pressure of patients undergoing HBO₂ therapy is a less defined potential side effect. We sought to better quantify effects of HBO₂ on blood pressure (BP) in patients undergoing HBO₂.
Hyperbaric oxygen treatment effects on in vitro cultured umbilical cord blood CD34+ cells. [2019]Label="BACKGROUND AIMS">Umbilical cord blood (UCB) provides an alternative source for hematopoietic stem/progenitor cells (HSPCs) in the treatment of hematological malignancies. However, clinical usage is limited due to the low quantity of HSPCs in each unit of cord blood and defects in bone marrow homing. Hyperbaric oxygen (HBO) is among the more recently explored methods used to improve UCB homing and engraftment. HBO works by lowering the host erythropoietin before UCB infusion to facilitate UCB HSPC homing, because such UCB cells are not directly exposed to HBO. In this study, we examined how direct treatment of UCB-CD34+ cells with HBO influences their differentiation, proliferation and in vitro transmigration.
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]There is a striking need for additional therapies of bone marrow oedema (BME) and aseptic osteonecrosis (AON) in paediatric oncology patients. Hyperbaric oxygenation (HBO) therapy used in the treatment of osteoradionecrosis is demonstrated effectiveness. Aim of this retrospective analysis was to investigate whether HBO-therapy might lead to subjective as well as objective effects in the treatment of BME and/or AON in paediatric oncology patients with acute lymphoblastic leukaemia (ALL) or Non-Hodgkin lymphoma (NHL).
Results of the First Clinical Study in Humans That Combines Hyperbaric Oxygen Pretreatment with Autologous Peripheral Blood Stem Cell Transplantation. [2020]Patients undergoing high-dose chemotherapy and autologous hematopoietic cell transplantation (auto-HCT) are at risk for multiple morbidities, including mucosal inflammation and neutropenic fever, both related to neutropenia. Evidence from our preclinical work in an umbilical cord blood (UCB) transplantation murine model suggests that treatment with hyperbaric oxygen (HBO) before UCB infusion improves UCB CD34+ cell engraftment by reducing erythropoietin levels. A pilot clinical trial using HBO in patients undergoing UCB transplantation showed improvement in kinetics of blood count recovery. In this study, we evaluated HBO in combination with auto-HCT. Our primary aim was to determine the safety of HBO in this setting and secondarily to determine its efficacy in reducing time to neutrophil and platelet engraftment compared with matched historic controls. Patients with multiple myeloma, non-Hodgkin lymphoma, and Hodgkin disease eligible for auto-HCT were included. On day 0, patients received HBO treatment consisting of exposure to 2.5 atmosphere absolutes for a total of 90 minutes, in a monoplace hyperbaric chamber, breathing 100% oxygen. Six hours after the start of HBO, peripherally mobilized stem/progenitor cells were infused and patients were followed daily for toxicity and blood count recovery. All patients received daily granulocyte colony-stimulating factor starting on day +5 and until absolute neutrophil count (ANC) of ≥1500 or ANC of 500 for 3 consecutive days. A matched historic cohort of 225 patients who received auto-HCT between January 2008 and December 2012 was chosen for comparison and matched on sex, age, conditioning regimen, and disease type. We screened 26 patients for this study; 20 were treated and included in the primary analysis, and 19 completed the HBO therapy and were included in the secondary analysis. Although the median time to neutrophil count recovery was 11 days in both the HBO and control cohorts, the Kaplan-Meier estimates of the full distributions indicate that the time to neutrophil recovery was generally about 1 day sooner for HBO versus historical controls (log-rank P = .005; range, 9 to 13 for HBO patients and 7 to 18 for controls). The median time to platelet count recovery was 16 days (range, 14 to 21) for HBO versus 18 days (range, 11 to 86) for controls (log-rank P < .0001). In the secondary analysis comparing the HBO cohort who completed HBO therapy (n = 19) with our historical cohort, we evaluated neutropenic fever, growth factor use, mucositis, day +100 disease responses, and blood product use. HBO was associated with less growth factor use (median 6 days in HBO cohort versus median 8 days in controls, P < .0001). Packed RBC and platelet transfusion requirements were not statistically different between the 2 cohorts. Mucositis incidence was significantly lower in the HBO cohort (26.3% in HBO cohort versus 64.2% in controls, P = .002). HBO therapy appears to be well tolerated in the setting of high-dose therapy and auto-HCT. Prospective studies are needed to confirm potential benefits of HBO with respect to earlier blood count recovery, reduced mucositis, and growth factor use, and a cost-benefit analysis is warranted. © 2019 American Society for Blood and Marrow Transplantation.
Hyperbaric oxygen and radiotherapy. [2007]Hyperbaric oxygen (HBO) therapy is the inhalation of 100% oxygen at a pressure of at least 1.5 atmospheres absolute (150 kPa). It uses oxygen as a drug by dissolving it in the plasma and delivering it to the tissues independent of hemoglobin. For a variety of organ systems, HBO is known to promote new vessel growth into areas with reduced oxygen tension due to poor vascularity, and therewith promotes wound healing and recovery of radiation-injured tissue. Furthermore, tumors may be sensitized to irradiation by raising intratumoral oxygen tensions.
The influence of hyperbaric oxygenation on leukocyte viability and surface protein expression. [2013]Hyperbaric oxygenation was studied as a potential inducer of cell growth and differentiation in promyelocytic leukemic HL60 cells. We studied changes in HL60 cells exposed to hyperbaric oxygen, oxygen, or carbon dioxide for 72 h. The proliferation rate and viability of cells in the hyperbaric oxygenation groups were significantly lower (p