NCT03398200

Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma

HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Omar Aljitawi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-10
• Primary completion: 2022-09-30
• Completion: 2023-03-28
• First posted: 2018-01-12
• Last updated: 2025-02-07
• Results posted: 2023-11-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study