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Study was terminated early because the site that administered the hyperbaric oxygen treatment closed and an alternative site could not be identified.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Stem Cells Collected | Total stem cells collected from all participants at one week post-study treatment | one week post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Waheed, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Science | Little Rock | Arkansas | 72205 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Stem Cells Collected | Total stem cells collected from all participants at one week post-study treatment | Four of eight enrolled subjects completed the study. | Posted | Number | stem cells | one week post-treatment |
|
|
Approximately 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALP Increased | Blood and lymphatic system disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Waheed, MD | University of Arkansas for Medical Science-MIRT | 501-686-8230 | mirt@uams.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| Alopecia | General disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Auditory/Ear-other | Ear and labyrinth disorders | Systematic Assessment |
|
| Bicarbonate decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine Increased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Upper airway - NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pain - Buttock | General disorders | Systematic Assessment |
|
| Pain - Middle ear | Ear and labyrinth disorders | Systematic Assessment |
|
| Pain - upper back | General disorders | Systematic Assessment |
|
| Pain - joint | General disorders | Systematic Assessment |
|
| Pulmonary - other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SGOT Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| SGPT Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |