Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
This study is currently recruiting participants.
Verified March 2013 by University of Arkansas
Sponsor:
University of Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01449539
First received: September 6, 2011
Last updated: March 1, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449539
Contacts
| Contact: Nathan Petty | 5015266990 ext 2435 | pettynathanm@uams.edu |
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Science | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Nathan Petty 501-526-5990 ext 2435 pettynathanm@uams.edu | |
| Principal Investigator: Sarah Waheed, MD | |
| Sub-Investigator: Gary Villines, MD | |
| Sub-Investigator: Bart Barlogie, MD., PhD | |
| Sub-Investigator: Michelle Fox, MD | |
| Sub-Investigator: Zeba Singh, MD | |
| Sub-Investigator: Daohong Zhou, MD | |
| Sub-Investigator: Antje Hoering, PhD | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Sarah Waheed, MD | University of Arkansas |
More Information
Additional Information:
Related Info 
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: | March 1, 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 May 19, 2013