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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00165438
• Collaborator: Brigham and Women's Hospital (Other)
• Enrollment: 60
• Locations: 2
• Duration (Months): 99
• Patients Per Site: 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Disease	Procedure: Pulmonary Function Tests; Procedure: CAT Scan

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• 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
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Jan 1, 2010

Outcome Measures

Primary Outcome Measures

1. Pulmonary function [2 years]

   Changes in pulmonary function over time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Dana-Farber Cancer Institute	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea K. Ng, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00165438
• Other Study ID Numbers: 01-181
• First Posted: Sep 14, 2005
• Last Update Posted: Dec 20, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Andrea K. Ng, MD, Principal Investigator, Dana-Farber Cancer Institute: Pulmonary function; Bleomycin-based chemotherapy; mediastinal irradiation
• Additional relevant MeSH terms: Hodgkin Disease

Study Results

No Results Posted as of Dec 20, 2012