Using hyperbaric oxygen therapy with stem cell transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.