Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/15/2017 |
Start Date: | March 2014 |
End Date: | August 2017 |
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
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
- 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
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.
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.
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
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