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| Name | Class |
|---|---|
| SWOG Cancer Research Network | NETWORK |
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By doing this study, researchers hope to learn the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Treatment | Experimental | Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of hyperbaric oxygen | Device | Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Aljitawi, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| 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. |
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |