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Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT00165438
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 20, 2012
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrea K. Ng, MD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given with or without chest radiation therapy, on patients' lung function over time.

Condition or disease Intervention/treatment
Hodgkin's Disease Procedure: Pulmonary Function Tests Procedure: CAT Scan

Detailed Description:
  • The tests and procedures in this study are part of regular cancer care but this study offers more structured timing of these standard tests.
  • Due to the potential lung toxicity associated with bleomycin-based chemotherapy, pulmonary function tests are routinely performed. Pulmonary function tests will be performed by a licensed, registered respiratory therapist and performed prior to the beginning of treatment, between the chemotherapy and radiation therapy (only for patients receiving both chemotherapy and radiation therapy), and at approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
  • A CAT scan will be performed prior to the beginning of treatment, and approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
  • A self-administered questionnaire will be performed on the days the patient is undergoing pulmonary function tests.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation
Study Start Date : October 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease
U.S. FDA Resources


Intervention Details:
    Procedure: Pulmonary Function Tests
    Tests include; total lung capacity, vital capacity, functional residual capacity, forced vital capacity, forced expiratory volume in 1 second, carbon monoxide diffusing capacity, pulse oximetry before and after a 6 minute walk and Pulmonary Status and Dyspnea Questionnaire
    Procedure: CAT Scan
    Obtained at different time points during the study depending upon standard of care chemotherapy treatment


Primary Outcome Measures :
  1. Pulmonary function [ Time Frame: 2 years ]
    Changes in pulmonary function over time



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed classic Hodgkin's disease with mediastinal involvement in whom bleomycin-based chemotherapy alone or bleomycin-based chemotherapy and mediastinal irradiation are recommended as initial treatment.
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed classical Hodgkin's disease, with mediastinal involvement
  • Bleomycin-based chemotherapy alone or in combination with mediastinal irradiation

Exclusion Criteria:

  • Prior chest irradiation
  • Mediastinal irradiation received at an outside institution
  • Refractory or progressive disease on treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165438


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Andrea K. Ng, MD, MPH Dana-Farber Cancer Institute

Responsible Party: Andrea K. Ng, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165438     History of Changes
Other Study ID Numbers: 01-181
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Andrea K. Ng, MD, Dana-Farber Cancer Institute:
Pulmonary function
Bleomycin-based chemotherapy
mediastinal irradiation

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents