N/A N=15 Treatment

Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

Acute Myeloid Leukemia · Acute Lymphoblastic Leukemia · Myelodysplastic Syndrome (MDS) · Hodgkins Lymphoma · Non-Hodgkins Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02099266 ↗

Enrolled (actual)

Serious AEs

46.7%

Results posted

Mar 2017

Primary outcome: Primary: Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation — 15; 12; 12; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Administration of hyperbaric oxygen (Device)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: University of Kansas Medical Center
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation	15; 12; 12; 13	—
SECONDARY Determine the Effects of HBO Therapy on Neutrophil Count Recovery.	7; 24.5	—
SECONDARY Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.	7	—

Summary

By doing this study, researchers hope to learn the following: * If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process * The safety of HBO administration in the setting of the UBC transplant * The effects of HBO therapy on the engraftment process

Eligibility Criteria

Inclusion Criteria

Voluntary written informed consent
Subjects must be >/= 17 yrs and /= 17 yrs and /= 70%
Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
ALT (alanine aminotransferase), AST (aspartate aminotransferase: /= 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)

Exclusion Criteria

Pregnancy or breast feeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax
History of seizures
Claustrophobia
Asthma
Uncontrolled viral or bacterial infection at the time of enrollment
Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02099266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.