Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation (DLNO/DLCO-HSCT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01735526
First received: November 24, 2012
Last updated: September 29, 2013
Last verified: November 2012
  Purpose

Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be hypothesized that these changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.


Condition
Lung Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Allogeneic Versus Autologous Hematopoietic Stem-cell Transplantation

Resource links provided by NLM:


Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • Changes in DLNO/DLCO ratio after allo- versus autologous HSCT [ Time Frame: Before and 2-6 months after HSCT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in lung tissue density after allo- versus autologous HSCT [ Time Frame: Before and 2-6 months after HSCT ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

In allogeneic hematopoietic stem-cell transplantation (allo-HSCT) recipients, early reductions of absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (IPS)[PMID: 22221781]. Two months after allo-HSCT, we have recently shown an increase in lung tissue density determined by quantitative CT scan [PMID: 22898044]. It can be hypothesized that these parenchymal changes might be due to an occult intersitial lung disease associated with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens or any combination of these [PMID: 21531955]. To test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (DLNO) and DLCO. Assuming, for clinical purposes, that the reaction rate of NO with blood hemoglobin is infinite so that DLNO = DMNO = DMCO*alpha (alpha = NO/CO diffusivity ratio), as to partition the effect of HSCT on membrane diffusing capacity (DM) and pulmonary capillary volume (Vc) we will use the DLNO/DLCO ratio [PMID:16478855]. As we hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT) recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with those of subjects undergoing allo-HSCT.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All consecutive patients undergoing allogeneic and autologous HSCT for hematological malignancies.

Criteria

Inclusion Criteria:

  • baseline spirometry, lung volumes, and DLCO of the subjects included in the analysis must be within the predicted normal range
  • all patients must be in stable clinical conditions at the time of study

Exclusion Criteria:

  • a history of bronchial asthma, chronic obstructive pulmonary disease, or other significant respiratory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735526

Locations
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Investigators
Principal Investigator: Giovanni Barisione, MD IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  More Information

Publications:
Responsible Party: Giovanni Barisione, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01735526     History of Changes
Other Study ID Numbers: 33/2012
Study First Received: November 24, 2012
Last Updated: September 29, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Allogeneic and autologous
hematopoietic stem-cell transplantation
Lung diffusing capacity
for nitric oxide
carbon monoxide
Lung tissue density
microvascular damage

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Carbon Monoxide
Nitric Oxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014