Clinical trial · Interventional
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant
NCT02087657CI-TRIAL-00025954Auto-HBOunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of hyperbaric oxygen | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperbaric Oxygen Treatment
- description
- Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).
- interventionNames
- Device: Administration of hyperbaric oxygen
Primary outcomes (1)
- measure
- Presence or absence of a treatment limiting toxicity
- timeFrame
- Toxicity assessment occurs within 24hrs of treatment
- description
- 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 outcomes (1)
- measure
- Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.