Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
NCT ID: NCT02087657
Last Updated: 2017-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-03-31
2017-08-31
Brief Summary
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* The safety of hyperbaric oxygen administration in the setting of the autologous transplant
* The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).
Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Interventions
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Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with Multiple Myeloma (MM), Hodgkin's Disease (HD), and non-Hodgkins lymphoma (NHL) who are eligible for high-dose chemotherapy and autologous PBSC transplant. Subjects should be enrolled within 30 days of transplant.
* Subjects must be \>/= 18 yrs old and \</= 70 yrs old
* Karnofsky performance status of \>/= 70%
* Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
* ALT (alanine aminotransferase), AST (aspartate aminotransferase): \< 4x IULN (institutional upper limit of normal)
* Total bilirubin: \</= 2.0 mg/dL
* Creatinine: \</= 2.0 mg/dL
* EF (ejection fraction) measured by 2D-ECHO or MUGA (multiple gated acquisition) scan of \>/= 45%
* FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD(diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin)
* Women of child-bearing potential and men with partners of child-bearing potential must use adequate contraception prior to study entry and up to 30 days following treatment.
Exclusion Criteria
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* Active ear/sinus infection
* Claustrophobia
* HIstory of sinus or ear surgery, excluding myringotomy or ear tubes
* History of seizures
18 Years
70 Years
ALL
No
Sponsors
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SWOG Cancer Research Network
NETWORK
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Omar Aljitawi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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Auto-HBO
Identifier Type: -
Identifier Source: org_study_id
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