Effects of Hyperbaric Oxygen (HBO) on Blood Count Recovery After Autologous Hematopoietic Stem Cell (HSPC) Transplant for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03398200|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Biological: Hyperbaric Oxygen Therapy Other: No Hyperbaric Oxygen Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HBO Effects on Blood Count Recovery and Post-transplant Outcomes Following High-dose Therapy and Autologous HSPC Transplantation for Multiple Myeloma|
|Actual Study Start Date :||May 10, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
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).
Active Comparator: No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
Other: No Hyperbaric Oxygen Therapy
The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
- Time from transplant to neutrophil count recovery [ Time Frame: 100 days ]
- Time from transplant to platelet recovery [ Time Frame: 100 days ]
- Time from transplant to absolute lymphocyte recovery [ Time Frame: 100 days ]
- Number of days of granulocyte colony-stimulating factor [ Time Frame: 100 days ]
- Number of units of packed red blood cells received [ Time Frame: 100 days ]
- Length of hospital stay [ Time Frame: 100 days ]
- Sustained freedom from myeloma [ Time Frame: 100 days and 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398200
|Contact: Omar Aljitawi, MD||585-275-5823||Omar_Aljitawi@urmc.rochester.edu|
|Contact: Erin Cebula, MPH||585-275-3883||Erin_Cebula@urmc.rochester.edu|
|United States, New York|
|Wilmot Cancer Institute, University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Erin Cebula, MPH 585-275-3883 Erin_Cebula@urmc.rochester.edu|
|Principal Investigator:||Omar Aljitawi, MD||Wilmot Cancer Institute|