Hyperbaric Oxygen Therapy for Leukemia
Recruiting in Palo Alto (17 mi)
Overseen byOmar S Aljitawi, MBBS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Omar Aljitawi
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if hyperbaric oxygen therapy is safe and effective for patients with certain types of chronic leukemia undergoing stem cell transplantation. The therapy involves breathing pure oxygen in a pressurized chamber to help the body heal and fight infections. Researchers hope it will improve outcomes like the success of the transplant and reduce problems like inflammation and infections. Hyperbaric oxygen therapy has been studied for its potential to improve outcomes in patients undergoing stem cell transplantation by enhancing the success of the transplant and reducing problems.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your medications with the study team to ensure they don't interfere with the trial.
What data supports the idea that Hyperbaric Oxygen Therapy for Leukemia is an effective treatment?
The available research shows that Hyperbaric Oxygen Therapy (HBOT) has been considered as a new treatment strategy for osteonecrosis, a complication in children with acute lymphoblastic leukemia (ALL). However, the studies on HBOT for this condition are of low-quality evidence, and there is a lack of safety and efficacy studies. Therefore, there is not enough strong data to support HBOT as an effective treatment for leukemia itself. In comparison, bone marrow transplantation has shown promising results with high survival rates, especially when performed during the first remission of leukemia.
12345What safety data exists for hyperbaric oxygen therapy?
Hyperbaric oxygen therapy (HBOT) is generally considered safe, but it can have side effects such as barotrauma, central nervous system and pulmonary oxygen toxicity, claustrophobia, anxiety, visual disturbances, and seizures. Middle-ear barotrauma is a common concern, and seizures, although rare, are one of the more severe side effects. A systematic review and meta-analysis have been conducted to understand these adverse effects better. In animal studies, renal damage was observed, suggesting potential dose-dependent effects.
678910Is Hyperbaric Oxygen Therapy a promising treatment for leukemia?
The provided research articles do not mention Hyperbaric Oxygen Therapy as a promising treatment for leukemia. They focus on other treatments like targeted drugs, bone marrow transplants, and differentiation therapy, which have shown significant progress in treating leukemia.
511121314Eligibility Criteria
Adults aged 18-75 with certain blood disorders like chronic myelomonocytic leukemia and myelofibrosis, who are fit enough for a stem cell transplant. They must have good heart, liver, kidney, and lung function and agree to use contraception. People with active infections or other cancers, recent ear/sinus issues or surgeries, severe asthma or COPD requiring oxygen can't join.Inclusion Criteria
I am able to care for myself but may not be able to do active work.
Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately
I am between 18 and 75 years old.
+12 more
Exclusion Criteria
Claustrophobia
My asthma is not well-managed.
I have had a fungal infection in the past 6 months without approval from a specialist.
+12 more
Participant Groups
The trial is testing if hyperbaric oxygen therapy is safe during stem cell transplants and if it helps with graft success, reduces mouth/gut inflammation (mucositis), infection rates, and improves white blood cell counts in patients with specific types of leukemia or myelodysplastic syndromes.
2Treatment groups
Experimental Treatment
Group I: Cohort 2- CMML, aCML, CML, CNL, MDS/MPNExperimental Treatment1 Intervention
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Group II: Cohort 1- AML or MDSExperimental Treatment1 Intervention
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wilmot Cancer Institute, University of RochesterRochester, NY
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Who Is Running the Clinical Trial?
Omar AljitawiLead Sponsor
References
Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia: Early Diagnosis and New Treatment Strategies. [2019]In the last few decades, treatment strategies for acute lymphoblastic leukemia (ALL) have been associated not only with improvement of prognosis, but also with an increasing rate of late complication as osteonecrosis (ON). Herein, the cumulative incidence, risk factors, new conservative therapeutic strategies as hyperbaric oxygen therapy (HBO), and outcome of symptomatic ON were studied in pediatric patients with ALL.
Neurologic complications of leukemia. [2013]As treatment of the leukemias improves, patients are surviving longer. Recognizing and rapidly treating metastatic complications or avoiding neurotoxic therapies improves outcome, reduces morbidity and mortality, and limits long-term sequelae.
Management and treatment of osteonecrosis in children and adolescents with acute lymphoblastic leukemia. [2021]There is no consensus regarding how to manage osteonecrosis in pediatric acute lymphoblastic leukemia patients. Therefore, we performed a quality assessment of the literature with the result of a search strategy using the MESH terms osteonecrosis, children, childhood cancer, surgery, bisphosphonates, 6 hydroxymethyl-glutaryl CoA reductase inhibitors, anticoagulants and hyperbaric oxygen, and terms related to these MESH terms. A randomized controlled trial showed that osteonecrosis can be prevented by intermittent, instead of continuous, corticosteroid administration. The studies on interventions after onset of osteonecrosis were of low-quality evidence. Seven pediatric acute lymphoblastic leukemia studies described non-surgical interventions; bisphosphonates (n=5), hyperbaric oxygen therapy (n=1), or prostacyclin analogs (n=1). Safety and efficacy studies are lacking. Five studies focused on surgical interventions; none was of sufficient quality to draw definite conclusions. In conclusion, preventing osteonecrosis is feasible in a proportion of the pediatric acute lymphoblastic leukemia patients by discontinuous, instead of continuous, steroid scheduling. The questions as to how to treat childhood acute lymphoblastic leukemia patients with osteonecrosis cannot be answered as good-quality studies are lacking.
[Bone marrow transplantation after intensive chemotherapy]. [2013]Bone marrow transplantation (BMT) after intensive marrow-lethal chemotherapy and total body irradiation has made remarkable progress in recent years. In allogeneic BMT, HLA-matched marrow cells of siblings are used, while in autologous BMT, cryopreserved leukemia-purged marrow cells from patients are employed. In 1985, about 100 BMT cases were registered in the Japan BMT study group. Interstitial pneumonitis caused by cytomegalovirus, relapse of leukemia, graft versus host disease, and bacterial infection were major cases of failure, which have shown a markedly reduced tendency in recent years. The timing of BMT was found to be very important for the survival of patients. In cases with acute lymphoblastic leukemia, if BMT was performed in the first remission, the long survival rate was 76%, while this rate was low for second or subsequent remissions. It was also found in patients with chronic myelogenous leukemia, that the survival rate was high in the chronic phase and low in the accelerated or blastic phase. BMT seems to be a very promising therapy for leukemia and related malignant diseases with a very high possibility of complete cure.
Bone marrow transplantation in leukemia. [2007]Bone marrow transplants are increasingly being used as treatment for leukemia. Several IBMTR studies have identified variables predicting outcome in allogeneic transplants. These studies have also identified factors like GVL that increase our understanding of leukemia treatment. Following the success of HLA-identical sibling transplants, allografts from related and unrelated donors are now performed frequently and achieve long-term LFS. The use of autologous transplants, with and without marrow treatment, is also increasing and continues to be investigated as an alternative therapy for leukemia.
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.
Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]Hyperbaric oxygen (HBO2) therapy is a safe and well-tolerated treatment modality. Seizures, one of the most severe central nervous system side effects of HBO2 therapy, can occur. Episodes of seizures during HBO2 therapy have not yet been reported in countries such as Korea, where hyperbaric medicine is still in the developmental stage.
The effect of hyperbaric oxygen therapy on kidneys in a rat model. [2022]Hyperbaric oxygen therapy (HBOT) is used for treating various medical conditions. As far as known yet, HBOT is safe with few major side effects that are easy to avoid using a proper protocol. Renal tubular damage was observed in rats exposed to HBOT in a preliminary study conducted in our institution. Aim. We aim to assess whether HBOT causes renal damage and, if so, whether this is dose dependent.
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.
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.
Treatment by design in leukemia, a meeting report, Philadelphia, Pennsylvania, December 2002. [2018]Novel approaches have been designed to treat leukemia based on our understanding of the genetic and biochemical lesions present in different malignancies. This meeting report summarizes some of the recent advances in leukemia treatment. Based on the discoveries of cellular oncogenes, chromosomal translocations, monoclonal antibodies, multidrug resistance pumps, signal transduction pathways, genomics/proteonomic approaches to clinical diagnosis and mutations in biochemical pathways, clinicians and basic scientists have been able to identify the particular genetic mutations and signal transduction pathways involved as well as design more appropriate treatments for the leukemia patient. This meeting report discusses these exciting new therapies and the results obtained from ongoing clinical trials. Furthermore, rational approaches to treat complications of tumor lysis syndrome by administration of the recombinant urate oxidase protein, also known as rasburicase, which corrects the biochemical defect present in humans, were discussed. Clearly, over the past 25 years, molecular biology and biotechnology has provided the hematologist/oncologist novel bullets in their arsenal that will allow treatment by design in leukemia.
The history of leukemia therapy--a personal journey. [2012]The advances in leukemia therapy which occurred during one professional lifetime of the author is described, and forms the basis for projecting the probable progress which will occur in a subsequent professional lifetime. These advances in leukemia therapy have rapidly found application to 'solid tumors,' suggesting that the road to cancer control will be led by discoveries made in leukemia biology, treatment, and prevention.
The cure of leukemia through the optimist's prism. [2023]Progress is occurring at a dizzying rate across all leukemias. Since the authors' review of the topic in Cancer in 2018, numerous discoveries have been made that have improved the therapy and outcomes of several leukemia subsets. Hairy cell leukemia is potentially curable with a single course of cladribine followed by rituximab (10-year survival, ≥90%). Acute promyelocytic leukemia is curable at a rate of 80% to 90% with a nonchemotherapy regimen of all-trans retinoic acid and arsenic trioxide. The cure rate for core-binding factor acute myeloid leukemia (AML) is ≥75% with fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin. Survival for patients with chronic myeloid leukemia is close to that for an age-matched normal population with BCR-ABL1 tyrosine kinase inhibitors (TKIs). Chronic lymphocytic leukemia, a previously incurable disease, may now be potentially curable with a finite duration of therapy with Bruton tyrosine kinase inhibitors and venetoclax. The estimated 5-year survival rate for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) exceeds 70% with intensive chemotherapy and ponatinib, a third-generation BCR-ABL1 TKI, and more recent nonchemotherapy regimens using dasatinib or ponatinib with blinatumomab are producing outstanding results. Survival in both younger and older patients with ALL has improved with the addition of antibodies targeting CD20, CD19 (blinatumomab), and CD22 (inotuzumab) to chemotherapy. Several recent drug discoveries (venetoclax, FLT3 and IDH inhibitors, and oral hypomethylating agents) are also improving outcomes for younger and older patients with AML and for those with higher risk myelodysplastic syndrome.
Cytokines in the differentiation therapy of leukemia: from laboratory investigations to clinical applications. [2019]Differentiation therapy of leukemia is the treatment of leukemia cells with biological or chemical agents that induce the terminal differentiation of the cancer cells. It is regarded as a novel and targeted approach to leukemia treatment, based on our better understanding of the hematopoietic process and the mechanisms of its deregulation during leukemogenesis. Clinically, differentiation therapy has been most successful in acute promyelocytic leukemia using all-trans-retinoic acid as the inducer, either alone or in combination with chemotherapy. This review presents evidence that a number of hematopoietic cytokines play important roles in both normal and aberrant hematopoietic processes. In vitro laboratory investigations in the past two decades using well-characterized myeloid leukemic cell lines and primary blast cells from leukemia patients have revealed that many hematopoietic cytokines can trigger lineage-specific differentiation of leukemia cells, which may have important implications in the clinical setting. Moreover, our current understanding of cytokine interactions and the molecular mechanisms of cytokine-induced leukemic cell differentiation will be discussed in the light of recent findings. Finally, ways in which laboratory research on cytokines in the differentiation therapy of leukemia can lead to the improved design of protocols for future clinical applications to leukemia therapy will also be addressed.