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

Primary Purpose

Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of hyperbaric oxygen
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Peripheral Blood Stem Cell (PBSC) Transplant, Hyperbaric oxygen, Lymphoma, Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

  • Pregnant or breast feeding
  • Severe chronic obstructive pulmonary disease requiring oxygen supplementation
  • History of spontaneous pneumothorax
  • Active ear/sinus infection
  • Claustrophobia
  • HIstory of sinus or ear surgery, excluding myringotomy or ear tubes
  • History of seizures

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric Oxygen Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Presence or absence of a treatment limiting toxicity
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.
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.

Full Information

First Posted
March 12, 2014
Last Updated
February 13, 2017
Sponsor
University of Kansas Medical Center
Collaborators
SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT02087657
Brief Title
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
Acronym
Auto-HBO
Official Title
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
SWOG Cancer Research Network

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
Keywords
Peripheral Blood Stem Cell (PBSC) Transplant, Hyperbaric oxygen, Lymphoma, Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Treatment
Arm Type
Experimental
Arm Description
Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).
Intervention Type
Device
Intervention Name(s)
Administration of hyperbaric oxygen
Other Intervention Name(s)
Monoplace Hyperbaric Chamber Model 3200 and 3200R
Intervention Description
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Primary Outcome Measure Information:
Title
Presence or absence of a treatment limiting toxicity
Description
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.
Time Frame
Toxicity assessment occurs within 24hrs of treatment
Secondary Outcome Measure Information:
Title
Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.
Description
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.
Time Frame
Daily measurement of neutrophil counts, up to 40 days post transplant.
Other Pre-specified Outcome Measures:
Title
Explore the effects of hyperbaric oxygen (HBO) therapy on erythropoietin (EPO) levels.
Description
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.
Time Frame
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
Title
Examine correlation between change to erythropoietin (EPO) levels and time to neutrophil recovery and engraftment.
Description
Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between erythropoietin levels and subsequent engraftment and neutrophil recovery.
Time Frame
EPO measurments: Pre-HBO (Day 0), 6-10hrs post-HBO, 24hrs and 48hrs post HBO, as well as 3 days post neutrophil engraftment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: Pregnant or breast feeding Severe chronic obstructive pulmonary disease requiring oxygen supplementation History of spontaneous pneumothorax Active ear/sinus infection Claustrophobia HIstory of sinus or ear surgery, excluding myringotomy or ear tubes History of seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Aljitawi, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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