Auto-HBO: Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02087657

Collaborator

Southwest Oncology Group (Other)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

By doing this study, researchers hope to learn the following:

The safety of hyperbaric oxygen administration in the setting of the autologous transplant
The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Hodgkin's Disease Non-Hodgkin's Lymphoma	Device: Administration of hyperbaric oxygen	N/A

Detailed Description

The post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. The investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. The idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) CD34+ stem cell transplantation.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperbaric Oxygen Treatment Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).	Device: Administration of hyperbaric oxygen Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours Other Names: Monoplace Hyperbaric Chamber Model 3200 and 3200R

Arm

Intervention/Treatment

Experimental: Hyperbaric Oxygen Treatment

Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).

Device: Administration of hyperbaric oxygen

Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Other Names:

Monoplace Hyperbaric Chamber Model 3200 and 3200R

Outcome Measures

Primary Outcome Measures

Presence or absence of a treatment limiting toxicity [Toxicity assessment occurs within 24hrs of treatment]
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: seizure disorder, pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy.

Secondary Outcome Measures

Reduction in time to neutrophil recovery and engraftment post-cord blood transplant. [Daily measurement of neutrophil counts, up to 40 days post transplant.]
Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of > 500/mm3. If subjects do not exhibit neutrophil recovery by Day 40 post transplant, they will be considered primary graft failures.

Other Outcome Measures

Explore the effects of hyperbaric oxygen (HBO) therapy on erythropoietin (EPO) levels. [Assessment at: Day -7 (lymphoma) or Day -3 (myeloma), Pre-HBO (Day 0), Pre-transplant (6-10hrs post-HBO), 24 and 48 hrs after starting hyperbaric oxygen treatment as well as 3 days post-neutrophil engraftment]
Statistical methods will be applied to determine if the mean erythropoietin levels during the first 24 hours and 48 hours correlate with time to neutrophil recovery and engraftment.
Examine correlation between change to erythropoietin (EPO) levels and time to neutrophil recovery and engraftment. [EPO measurments: Pre-HBO (Day 0), 6-10hrs post-HBO, 24hrs and 48hrs post HBO, as well as 3 days post neutrophil engraftment.]
Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between erythropoietin levels and subsequent engraftment and neutrophil recovery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Voluntary written informed consent
Subjects with Multiple Myeloma (MM), Hodgkin's Disease (HD), and non-Hodgkins lymphoma (NHL) who are eligible for high-dose chemotherapy and autologous PBSC transplant. Subjects should be enrolled within 30 days of transplant.
Subjects must be >/= 18 yrs old and </= 70 yrs old
Karnofsky performance status of >/= 70%
Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant.

Minimum criteria include:

ALT (alanine aminotransferase), AST (aspartate aminotransferase): < 4x IULN (institutional upper limit of normal)
Total bilirubin: </= 2.0 mg/dL
Creatinine: </= 2.0 mg/dL
EF (ejection fraction) measured by 2D-ECHO or MUGA (multiple gated acquisition) scan of >/= 45%
FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD(diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin)
Women of child-bearing potential and men with partners of child-bearing potential must use adequate contraception prior to study entry and up to 30 days following treatment.