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

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrea K. Ng, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165438
First received: September 9, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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 ] [ Designated as safety issue: No ]
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165438

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
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
  More Information

No publications provided

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
Study First Received: September 9, 2005
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014