Effects of Hyperbaric Oxygen (HBO) on Blood Count Recover... | NCT03398200

ID	Type	Description	Link
UBMT17083	Other Identifier	Wilmot Cancer Institute Clinical Trials Office

Label	Type	Description	Intervention Names
Hyperbaric Oxygen Therapy	Experimental	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.	Biological: Hyperbaric Oxygen Therapy
No Hyperbaric Oxygen Therapy	Active Comparator	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.	Other: No Hyperbaric Oxygen Therapy

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric Oxygen Therapy	Biological	The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).

Measure	Description	Time Frame
Time From Transplant to Neutrophil Count Recovery	Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count >=0.5 thou/ul after nadir.	100 days

Measure	Description	Time Frame
Time From Transplant to Absolute Lymphocyte Recovery		100 days
Number of Days of Granulocyte Colony-stimulating Factor		100 days
Number of Units of Packed Red Blood Cells Received

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary written informed consent.
Multiple myeloma diagnosis applying the latest criteria by International Working Group. Patients should have received myeloma-directed induction therapy with appropriate response (partial response or better) in newly diagnosed myeloma patients. Multiple myeloma patients who relapse following induction therapy or following prior autologous hematopoietic stem cell transplant are also eligible as far as remission following their first autologous hematopoietic stem cell transplant lasted 12 months or more.
Patients who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at Wilmot Cancer Institute will be screened for eligibility to enroll in this study and if eligible will be approached to participate. Eligible patients will have the chance to tour the hyperbaric oxygen facility prior to signing the consent form.
Subjects must be ≥ 18 years old and ≤ 75 years old.
Karnofsky performance status (KPS) of ≥ 70%.
Adequate hepatic, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST): < 4x institutional upper limit of normal (IULN)
- Total bilirubin: ≤ 2.0 mg/dL
- Ejection fraction (EF) measured by two-dimensional echocardiography (2D-ECHO) or multigated acquisition (MUGA) scan of ≥ 45%
- Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% of predicted value (corrected to serum hemoglobin)
- Electrocardiogram (EKG) with no clinically significant arrhythmia.
Patients should have New York Heart Association (NYHA) Functional Classification, class I or II (No or mild limitation during ordinary activity).
Patients should be evaluated for fitness for hyperbaric oxygen therapy by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.
Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.
Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

Pregnant or breastfeeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax
Active ear/sinus infection
History of sinus or ear surgery, excluding myringotomy or ear tubes
Claustrophobia
History of seizures
Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging
Prior chest surgery or irradiation
Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
Active infection (viral, fungal, and/or bacterial)
Positive screening for Hepatitis A, B, or C indicating an ongoing infection

Name	Affiliation	Role
Omar Aljitawi, MD	Wilmot Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Kansas Cancer Center		Fairway	Kansas	66205	United States
University of Kentucky Markey Cancer Center

ID	Title	Description
FG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 20, 2022

ID	Title	Description
BG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
BG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00052 BG00147 BG00299

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

Time From Transplant to Neutrophil Count Recovery

Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count >=0.5 thou/ul after nadir.

Posted

Mean

95% Confidence Interval

days

100 days

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
OG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Units	Counts
Participants	OG00052 OG00146

Title

Denominators

Categories

Title	Measurements
	OG00012(12 to 13) OG00112(12 to 13)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox	1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model	0.89														Superiority

Secondary

Time From Transplant to Absolute Lymphocyte Recovery

Posted

Median

95% Confidence Interval

Days

100 days

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
OG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Units	Counts
Participants

Secondary

Number of Days of Granulocyte Colony-stimulating Factor

Posted

Median

Inter-Quartile Range

Days

100 days

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
OG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Units	Counts
Participants

Secondary

Number of Units of Packed Red Blood Cells Received

Posted

Median

Inter-Quartile Range

units

100 days

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
OG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Units	Counts
Participants

Secondary

Length of Hospital Stay

Posted

Median

Inter-Quartile Range

Days

100 days

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
OG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.

Units	Counts
Participants

Secondary

Percentage of Participants With Progressive Free Survival

A progressive response is defined as follows:

Increase of > 25% from lowest response value in any one or more of the following:

Serum M-component and/or (the absolute increase must be > 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be > 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be > 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder

Anyone who did not have a progressive response was considered as progression free survival.

Posted

Number

95% Confidence Interval

percentage of participants

1 year

ID	Title	Description
OG000	Hyperbaric Oxygen Therapy	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Enterocolitis Infectious	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Atrial Fibrillation	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected52 at risk EG0011 affected47 at risk
Acute Kidney Injury	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Constipation	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected47 at risk
Immune System Disorders - Other, Engraftment Syndrome	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0011 affected47 at risk
Infections & Infestations - Other, Bacteremia	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Lung Infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected47 at risk
Nausea	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected47 at risk
Fatigue	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected47 at risk
Fever	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected47 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected47 at risk
Infections & Infestations - Other, MRSA	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected47 at risk
Upper Respiratory Infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected47 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00018 affected52 at risk EG0018 affected47 at risk
Acute Kidney Injury	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0015 affected47 at risk
ALT Increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0006 affected52 at risk EG0019 affected47 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00031 affected52 at risk EG00123 affected47 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00014 affected52 at risk EG00114 affected47 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected52 at risk EG00114 affected47 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected52 at risk EG0014 affected47 at risk
AST Increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0016 affected47 at risk
atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0011 affected47 at risk
Back Pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0009 affected52 at risk EG0018 affected47 at risk
Blood Bilirubin Increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0015 affected47 at risk
Blurred Vision	Eye disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0014 affected47 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0007 affected52 at risk EG0017 affected47 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0010 affected47 at risk
Chills	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0007 affected52 at risk EG0014 affected47 at risk
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0015 affected47 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00019 affected52 at risk EG00116 affected47 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0007 affected52 at risk EG0015 affected47 at risk
Creatinine Increased	Investigations	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0015 affected47 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00037 affected52 at risk EG00136 affected47 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0009 affected52 at risk EG00112 affected47 at risk
Dry Mouth	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected52 at risk EG00110 affected47 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0008 affected52 at risk EG0017 affected47 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0007 affected52 at risk EG0017 affected47 at risk
Ear & Labyrinth Disorders - Other, Ear Popping	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0010 affected47 at risk
Ear and Labyrinth Disorders - Other, Ear Pressure	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0010 affected47 at risk
Ear Pain	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment	EG0006 affected52 at risk EG0010 affected47 at risk
Edema Limbs	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00012 affected52 at risk EG00111 affected47 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0012 affected47 at risk
Fatigue	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG00036 affected52 at risk EG00130 affected47 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00030 affected52 at risk EG00123 affected47 at risk
Fever	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0017 affected47 at risk
Gastrointestinal Disorders - Other, abdominal crampin	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected52 at risk EG0013 affected47 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00013 affected52 at risk EG00112 affected47 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0013 affected47 at risk
Hypercalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0014 affected47 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0006 affected52 at risk EG0014 affected47 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG00014 affected52 at risk EG00113 affected47 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00022 affected52 at risk EG00118 affected47 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00040 affected52 at risk EG00137 affected47 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0014 affected47 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00020 affected52 at risk EG00127 affected47 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00012 affected52 at risk EG00114 affected47 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0016 affected47 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG00030 affected52 at risk EG00133 affected47 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG00013 affected52 at risk EG00110 affected47 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0007 affected52 at risk EG0014 affected47 at risk
Immune System Disorders - Other, Engraftment Syndrome	Immune system disorders	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected52 at risk EG0011 affected47 at risk
Infections & Infestations - Other, Bacteremia	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0004 affected52 at risk EG0015 affected47 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment	EG00017 affected52 at risk EG00115 affected47 at risk
Leukopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00040 affected52 at risk EG00137 affected47 at risk
Lung Infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0010 affected47 at risk
Lymphopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00036 affected52 at risk EG00134 affected47 at risk
Metabolism & nutritional disorders - other, insufficient oral intake	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0013 affected47 at risk
Mucositis Oral	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00022 affected52 at risk EG00117 affected47 at risk
Myalgia	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0014 affected47 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0012 affected47 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00042 affected52 at risk EG00136 affected47 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0013 affected47 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00042 affected52 at risk EG00138 affected47 at risk
Non-Cardiac Chest Pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0015 affected47 at risk
Pain	General disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0013 affected47 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0002 affected52 at risk EG0017 affected47 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00010 affected52 at risk EG00111 affected47 at risk
Pruitus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0013 affected47 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0012 affected47 at risk
Renal & Urinary Disorders - Other, Dysuria	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0012 affected47 at risk
Respiratory, Thoracic & Mediastinal Disorders - Other, runny nose	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0003 affected52 at risk EG0010 affected47 at risk
Sinus Bradycardia	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG0001 affected52 at risk EG0013 affected47 at risk
Sinus Tachycardia	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment	EG00016 affected52 at risk EG00111 affected47 at risk
Sore Throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0000 affected52 at risk EG0013 affected47 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment	EG00041 affected52 at risk EG00139 affected47 at risk
Thromboembolic Event	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0011 affected47 at risk
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG0005 affected52 at risk EG0013 affected47 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment	EG00022 affected52 at risk EG00119 affected47 at risk

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

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	Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).	0	52	12	52	49	52
EG001	No Hyperbaric Oxygen Therapy	Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.	0	47	9	47	39	47