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

Completed

• Conditions: Hodgkin's Disease

• Registration Number: NCT00165438
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2005-11
• Study Completion: 2010-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function	2 years	Changes in pulmonary function over time

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States