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

This study has been completed.
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrea K. Ng, MD, Dana-Farber Cancer Institute Identifier:
First received: September 9, 2005
Last updated: December 19, 2012
Last verified: December 2012
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 Intervention
Hodgkin's Disease
Procedure: Pulmonary Function Tests
Procedure: CAT Scan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

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

Enrollment: 60
Study Start Date: October 2001
Study Completion Date: January 2010
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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
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.

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00165438

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
Principal Investigator: Andrea K. Ng, MD, MPH Dana-Farber Cancer Institute
  More Information

Responsible Party: Andrea K. Ng, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00165438     History of Changes
Other Study ID Numbers: 01-181
Study First Received: September 9, 2005
Last Updated: December 19, 2012

Keywords provided by Dana-Farber Cancer Institute:
Pulmonary function
Bleomycin-based chemotherapy
mediastinal irradiation

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on May 23, 2017