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

NCT01449539 | Terminated Results DMC

• 1 other identifier: UARK 2010-43
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Hyperbaric oxygen; mobilize; stem cells; growth factor

Outcome Measures

Primary Outcomes (1)

• Number of Stem Cells Collected

  Total stem cells collected from all participants at one week post-study treatment

  one week post-treatment

Interventions

Hyperbaric Oxygen Therapy DRUG

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

Also known as: HBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Limitations and Caveats

Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified. Only four subjects completed the trial.

Results Point of Contact

• Title: Sarah Waheed, MD
• Organization: University of Arkansas for Medical Science-MIRT

mirt@uams.edu

501-686-8230

Study Officials

• Sarah Waheed, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: October 10, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

US (1)