Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation

Status unconfirmed · Not applicable

Conditions studied: Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma

In brief

By doing this study, researchers hope to learn the following: * 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

Key facts

Study ID

NCT02087657

Run by

University of Kansas Medical Center

People needed

20

Starts

2014-03-01

Expected to finish

2017-08-01

Last updated by the study team

2017-02-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary written informed consent
• 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.

You may not qualify if…

• Pregnant or breast feeding
• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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