Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
NCT03398200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2025-02-07
Summary
Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. Eligible patients who choose to participate will be randomized so that half receive one hyperbaric oxygen therapy session prior to hematopoetic stem cell infusion and half will not. All subjects will have their blood counts monitored closely and time to count recovery will be compared between the two groups.
Conditions
Interventions
- BIOLOGICAL
-
Hyperbaric Oxygen Therapy
The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
- OTHER
-
No Hyperbaric Oxygen Therapy
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
Sponsors & Collaborators
-
Omar Aljitawi
lead OTHER
Principal Investigators
-
Omar Aljitawi, MD · Wilmot Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-10
- Primary Completion
- 2022-09-30
- Completion
- 2023-03-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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