Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Hyperbaric oxygen, mobilize, stem cells, growth factor
Eligibility 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
Sites / Locations
- University of Arkansas for Medical Science
Outcomes
Primary Outcome Measures
Number of Stem Cells Collected
Total stem cells collected from all participants at one week post-study treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT01449539
First Posted
September 6, 2011
Last Updated
February 20, 2015
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01449539
Brief Title
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Official Title
Pilot Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified.
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Hyperbaric oxygen, mobilize, stem cells, growth factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Oxygen Therapy
Other Intervention Name(s)
HBOT
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Stem Cells Collected
Description
Total stem cells collected from all participants at one week post-study treatment
Time Frame
one week post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Waheed, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Science
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.myeloma.uams.edu
Description
Related Info
Learn more about this trial
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
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