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
  Purpose

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 Intervention
Multiple Myeloma
Drug: Hyperbaric Oxygen Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Number of stem cells collected [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449539

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

Additional Information:
No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01449539     History of Changes
Other Study ID Numbers: UARK 2010-43
Study First Received: September 6, 2011
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014