CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Hyperbaric Oxygen Therapy +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03398200
NCT03398200Phase 2Completed

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

Omar Aljitawi·interventional·Posted Jan 12, 2018·Updated Feb 7, 2025

In Brief

A Phase 2 clinical trial evaluating Hyperbaric Oxygen Therapy and No Hyperbaric Oxygen Therapy for Myeloma. Completed, enrolled 99 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 12, 2018
Enrollment StartMay 10, 2018
Primary CompletionSep 30, 2022
Study CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.5 years ago

Interventions

Hyperbaric Oxygen Therapybiological

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).

No Hyperbaric Oxygen Therapyother

The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.