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

Hodgkin's Disease Clinical Trial

Official title:

A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165438
• Other study ID #: 01-181
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: December 19, 2012
• Start date: October 2001
• Est. completion date: January 2010

Study information

• Verified date: December 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• 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
• CAT Scan
Obtained at different time points during the study depending upon standard of care chemotherapy treatment

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	Changes in pulmonary function over time	2 years	No