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

Not Applicable

• Conditions: Multiple Myeloma; Hodgkin's Disease; Non-Hodgkin's Lymphoma
• Interventions: Device: Administration of hyperbaric oxygen

• Registration Number: NCT02087657
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2016-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Treatment	Administration of hyperbaric oxygen	Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States