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

Multiple Myeloma Clinical Trial

— Auto-HBO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02087657
• Other study ID #: Auto-HBO
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2014
• Last updated: February 13, 2017
• Start date: March 2014
• Est. completion date: August 2017

Study information

• Verified date: February 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Southwest Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the effects of hyperbaric oxygen (HBO) therapy on erythropoietin (EPO) levels.	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.	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
Other	Examine correlation between change to erythropoietin (EPO) levels and time to neutrophil recovery and 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.	EPO measurments: Pre-HBO (Day 0), 6-10hrs post-HBO, 24hrs and 48hrs post HBO, as well as 3 days post neutrophil engraftment.
Primary	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.	Toxicity assessment occurs within 24hrs of treatment
Secondary	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.	Daily measurement of neutrophil counts, up to 40 days post transplant.