Actively Recruiting
A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation
Led by University of Rochester · Updated on 2025-07-08
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of hyperbaric oxygen (HBO) therapy to improve umbilical cord blood (UCB) stem cell transplant outcomes for blood and lymph gland cancers such as AML, NHL, Hodgkin Disease, and myelodysplastic syndrome. UCB transplant has advantages like easier access and lower risk of infections and graft versus host disease, but challenges include limited stem cell doses and problems with homing, where stem cells lodge in the bone marrow. This study aims to see if HBO given before transplant can improve homing and engraftment by reducing a hormone that may impair this process. Participants in this randomized phase II trial will be assigned to either receive hyperbaric oxygen therapy or no additional intervention before their UCB transplant. HBO therapy involves breathing 100% oxygen in a pressurized chamber at 2.5 times normal atmospheric pressure. The study compares time to neutrophil recovery and other blood count and transplant success measures within 100 days after transplant between the two groups. Participants will be monitored closely with blood tests to track recovery and engraftment, including neutrophil and platelet counts and donor cell presence. Safety assessments and evaluations of transplant outcomes will occur regularly during the first 100 days post-transplant. The study runs until June 2027 and aims to provide important information on whether HBO therapy improves transplant success and immune recovery.
CONDITIONS
Brief Title
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent
- Patients considered for allogeneic transplantation who lack matched donors or cannot proceed within 8 weeks
- Only patients eligible for reduced intensity conditioning (RIC) are included
- Diagnosed with AML, high-risk ALL, biphenotypic leukemia, undifferentiated leukemia, MDS/MPN with less than 10% blasts, chemotherapy-sensitive Hodgkin's or non-Hodgkin's lymphoma
- Age between 18 and 70 years
- Karnofsky performance status of 70% or higher
- Adequate liver, kidney, heart, and lung function meeting defined lab and test criteria
- NYHA functional class I or II
- Evaluated fit for hyperbaric oxygen therapy by a trained medical professional
- Negative pregnancy test for women of child-bearing potential within 4 weeks
- Use of adequate contraception during and 30 days after study participation for participants of child-bearing potential
You will not qualify if you...
- Pregnant or breastfeeding
- Severe chronic obstructive pulmonary disease requiring oxygen
- History of spontaneous pneumothorax
- Active ear or sinus infection unless cleared by specialist
- Evidence of pneumothorax or significant lung fibrosis within 60 days
- Prior chest surgery or direct chest irradiation
- Recent sinus or ear surgery within 5 years except minor procedures
- Claustrophobia
- Intrathecal chemotherapy within 2 weeks or cranial irradiation within 4 weeks before conditioning
- History of seizures
- Active tobacco use within 72 hours before transplant until recovery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks until transplant
Participants receive hyperbaric oxygen therapy prior to their umbilical cord blood stem cell transplant to improve stem cell homing and engraftment.
Multiple visits for hyperbaric oxygen therapy sessions before transplant
Duration - 100 days post-transplant
Participants are monitored for recovery of neutrophils, platelets, and transfusion independence after the transplant.
Regular visits for up to 100 days after transplant
Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
K
Kaitlyn Burrows
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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