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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01449539
First received: September 6, 2011
Last updated: September 9, 2013
Last verified: September 2013

September 6, 2011
September 9, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
Number of stem cells collected [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01449539 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01449539
UARK 2010-43
Yes
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Sarah Waheed, MD University of Arkansas
University of Arkansas
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP