Using hyperbaric oxygen therapy with stem cell transplants
A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem/Progenitor Transplantation
This study is testing whether hyperbaric oxygen therapy can help patients with chronic leukemias and myelofibrosis who are getting stem cell transplants feel better and recover more effectively.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT03964506 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and potential benefits of hyperbaric oxygen therapy in patients undergoing allogeneic peripheral blood stem cell transplantation. It focuses on two cohorts: one with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), and another with various chronic leukemias and myelofibrosis. The study aims to assess improvements in engraftment, graft versus host disease, neutrophil counts, and the incidence and severity of mucositis and infections. Currently, only the second cohort is being recruited as the first cohort has completed recruitment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with specific types of leukemia or myelodysplastic syndromes.
Not a fit: Patients with conditions outside the specified leukemias or those who do not meet the health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce complications for patients undergoing stem cell transplants.
How similar studies have performed: While the use of hyperbaric oxygen therapy is being explored in various contexts, this specific application in stem cell transplantation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary written informed consent * Men or women, age ≥ 18 years of age, with upper limit of 75 years old. * Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1. * Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2. * Karnofsky performance status (KPS) of ≥ 70% * Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain). * Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST \< 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin) * 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. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen Exclusion Criteria: * Pregnant or breastfeeding * Severe chronic obstructive pulmonary disease requiring oxygen supplementation * History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs * Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant. * Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome. * Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist. * Recent sinus surgery (within the last 5 years). * Ear surgery excluding myringotomy or ear tubes * Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed. * Claustrophobia * History of recurrent seizures within 5 years of study enrollment. * Uncontrolled asthma * Uncontrolled viral or bacterial infection at the time of study enrollment * Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval * Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
Where this trial is running
Rochester, New York
- Wilmot Cancer Institute, University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Omar S Aljitawi, MBBS — University of Rochester
- Study coordinator: Regulatory Coordinator
- Email: Lisa_Metzger@URMC.Rochester.edu
- Phone: (585) 276-7078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.