Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449539
Recruitment Status : Terminated (Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified.)
First Posted : October 10, 2011
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Hyperbaric Oxygen Therapy Not Applicable

Detailed Description:
Subjects will receive HBOT daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. The role of HBOT in stem cell mobilization as well as its role on oxidative stress will be evaluated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Intervention Details:
  • Drug: Hyperbaric Oxygen Therapy
    Treatment Monday through Friday in a monoplace hyoerbaric chamber 100% oxygen at 2.0 atmospheres (14.7 PSI or the equivalent of being under 33 feet of sea water) for 90 minutes at pressure. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each subject will be treated for two weeks for a total of 10 HBOT treatments
    Other Name: HBOT

Primary Outcome Measures :
  1. Number of Stem Cells Collected [ Time Frame: one week post-treatment ]
    Total stem cells collected from all participants at one week post-study treatment

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who are being considered for autologous stem cell transplant as part of their routine care who have failed at least one prior attempt at stem cell mobilization with any of currently available standard regimens using growth factors.
  • Patients in who the use of Mozobil® is medically justified but is not possible because of insurance or financial reasons
  • Patients scheduled to begin standard growth factor treatment with Neupogen® as part of routine care.
  • Patients who have had a bone marrow evaluation performed within one month prior to enrollment as part of routine clinical care or under IRB# 02815.
  • Patients who have had a chest x-ray or CT Chest within 60 days prior to enrollment.
  • ECOG performance status ≤ 3 performed within 60 days prior to enrollment which will be determined by history.
  • Patients who are at least 18 years of age at the time of registration.
  • Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.

Exclusion Criteria:

  • Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis within 60 days prior to enrollment.
  • History of New York Heart Association (NYHA) Class III or Class IV heart failure
  • Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias from medical history.
  • Untreated pneumothorax from medical history.
  • Uncontrolled seizure disorder from medical history
  • Uncontrolled insulin dependent diabetes (verified by routine labs in medical record)
  • History of severe claustrophobia
  • Severe COPD (FEV1 < 50% of predicted on pulmonary function test) performed within 60 days prior to enrollment
  • Untreated ear barotraumas from medical history
  • Pregnancy or currently breastfeeding (females of childbearing potential must agree to use adequate contraception during the study). A urine pregnancy test will be performed prior to initiating HBOT.
  • Patients currently receiving Bleomycin, Cisplatin, Disulfiram, Doxorubicin, and Sulfamylon.
  • Any other condition that the PI determines may jeopardize the safety of the subject during the course of the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT01449539

United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Sarah Waheed, MD University of Arkansas

Additional Information:
Responsible Party: University of Arkansas Identifier: NCT01449539     History of Changes
Other Study ID Numbers: UARK 2010-43
First Posted: October 10, 2011    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by University of Arkansas:
Hyperbaric oxygen
stem cells
growth factor

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action