Clinical trial NCT02087657: Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
Official title: Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Keywords: Peripheral Blood Stem Cell (PBSC) Transplant
Hyperbaric oxygen
Lymphoma
Myeloma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: SWOG Cancer Research Network
First posted: 2014-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Presence or absence of a treatment limiting toxicity
timeFrame: Toxicity assessment occurs within 24hrs of treatment
Secondary outcomes:
measure: Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.
timeFrame: Daily measurement of neutrophil counts, up to 40 days post transplant.
Other outcomes:
measure: Explore the effects of hyperbaric oxygen (HBO) therapy on erythropoietin (EPO) levels.
timeFrame: 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
measure: Examine correlation between change to erythropoietin (EPO) levels and time to neutrophil recovery and engraftment.
timeFrame: EPO measurments: Pre-HBO (Day 0), 6-10hrs post-HBO, 24hrs and 48hrs post HBO, as well as 3 days post neutrophil engraftment.
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Omar Aljitawi, MD
role: PRINCIPAL_INVESTIGATOR
References: