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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01449539
• Other study ID #: UARK 2010-43
• Status: Terminated
• Phase: N/A
• First received: September 6, 2011
• Last updated: February 20, 2015
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Science	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Stem Cells Collected	Total stem cells collected from all participants at one week post-study treatment	one week post-treatment	No

External Links

•   Link