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

University of Kansas

Status: Unknown

Conditions: Multiple Myeloma; Non-Hodgkin's Lymphoma; Hodgkin's Disease

Treatments: Device: Administration of hyperbaric oxygen

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02087657

Auto-HBO

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hyperbaric Oxygen Treatment

Experimental group

Description:

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

Treatment:

Device: Administration of hyperbaric oxygen