Trial Outcomes & Findings for Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization (NCT NCT01449539)
NCT ID: NCT01449539
Last Updated: 2015-02-23
Results Overview
Total stem cells collected from all participants at one week post-study treatment
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
one week post-treatment
Results posted on
2015-02-23
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Toxicity not study related
|
1
|
Baseline Characteristics
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization
Baseline characteristics by cohort
| Measure |
Hyperbaric Oxygen Therapy
n=8 Participants
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.
|
|---|---|
|
Age, Continuous
|
68.25 years
STANDARD_DEVIATION 50.185 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one week post-treatmentPopulation: Four of eight enrolled subjects completed the study.
Total stem cells collected from all participants at one week post-study treatment
Outcome measures
| Measure |
Hyperbaric Oxygen Therapy
n=4 Participants
Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
|
|---|---|
|
Number of Stem Cells Collected
|
8910000 stem cells
|
Adverse Events
Hyperbaric Oxygen Therapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyperbaric Oxygen Therapy
n=8 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
ALP Increased
|
62.5%
5/8 • Approximately 6 months.
|
|
General disorders
Alopecia
|
12.5%
1/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
8/8 • Approximately 6 months.
|
|
Ear and labyrinth disorders
Auditory/Ear-other
|
12.5%
1/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
Bicarbonate decrease
|
37.5%
3/8 • Approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
12.5%
1/8 • Approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
25.0%
2/8 • Approximately 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Approximately 6 months.
|
|
General disorders
Fatigue
|
37.5%
3/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
8/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
100.0%
8/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
4/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
37.5%
3/8 • Approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway - NOS
|
12.5%
1/8 • Approximately 6 months.
|
|
General disorders
Pain - Buttock
|
12.5%
1/8 • Approximately 6 months.
|
|
Ear and labyrinth disorders
Pain - Middle ear
|
25.0%
2/8 • Approximately 6 months.
|
|
General disorders
Pain - upper back
|
12.5%
1/8 • Approximately 6 months.
|
|
General disorders
Pain - joint
|
12.5%
1/8 • Approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
12.5%
1/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
SGOT Increased
|
12.5%
1/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
SGPT Increased
|
25.0%
2/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
8/8 • Approximately 6 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
4/8 • Approximately 6 months.
|
Additional Information
Sarah Waheed, MD
University of Arkansas for Medical Science-MIRT
Phone: 501-686-8230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place