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

This study has been terminated.
(Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified.)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01449539
First received: September 6, 2011
Last updated: February 20, 2015
Last verified: February 2015
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Hyperbaric Oxygen Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hyperbaric Oxygen Therapy Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens

Participant Flow:   Overall Study
    Hyperbaric Oxygen Therapy
STARTED   8 
COMPLETED   4 
NOT COMPLETED   4 
Withdrawal by Subject                3 
Toxicity not study related                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hyperbaric Oxygen Therapy Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.

Baseline Measures
   Hyperbaric Oxygen Therapy 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.25  (50.185) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   6 
Gender 
[Units: Participants]
 
Female   6 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   Number of Stem Cells Collected   [ Time Frame: one week post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sarah Waheed, MD
Organization: University of Arkansas for Medical Science-MIRT
phone: 501-686-8230
e-mail: mirt@uams.edu



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
Results First Received: November 21, 2014
Last Updated: February 20, 2015
Health Authority: United States: Institutional Review Board