NCT02087657

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

March 12, 2014

Last Update Submit

February 13, 2017

Conditions

Multiple MyelomaHodgkin's DiseaseNon-Hodgkin's Lymphoma

Keywords

Peripheral Blood Stem Cell (PBSC) TransplantHyperbaric oxygenLymphomaMyeloma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Reduction in time to neutrophil recovery and engraftment post-cord blood transplant.

    Daily measurement of neutrophil counts, up to 40 days post transplant.

Other Outcomes (2)

  • Explore the effects of hyperbaric oxygen (HBO) therapy on erythropoietin (EPO) levels.

    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

  • Examine correlation between change to erythropoietin (EPO) levels and time to neutrophil recovery and engraftment.

    EPO measurments: Pre-HBO (Day 0), 6-10hrs post-HBO, 24hrs and 48hrs post HBO, as well as 3 days post neutrophil engraftment.

Study Arms (1)

Hyperbaric Oxygen Treatment

EXPERIMENTAL

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

Device: Administration of hyperbaric oxygen

Interventions

Administration of hyperbaric oxygenDEVICE

Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Also known as: Monoplace Hyperbaric Chamber Model 3200 and 3200R
Hyperbaric Oxygen Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Multiple MyelomaHodgkin DiseaseLymphoma, Non-HodgkinLymphomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic Diseases

Study Officials

  • Omar Aljitawi, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(1)