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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 9, 2005
First Posted Date September 14, 2005
Last Update Posted Date December 20, 2012
Study Start Date October 2001
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2012)
Pulmonary function [ Time Frame: 2 years ]
Changes in pulmonary function over time
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy
Official Title A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hodgkin's Disease
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 9, 2005)
60
Original Enrollment Same as current
Actual Study Completion Date January 2010
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00165438
Other Study ID Numbers 01-181
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrea K. Ng, MD, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Brigham and Women's Hospital
Investigators
Principal Investigator: Andrea K. Ng, MD, MPH Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date December 2012