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

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.

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Key information

Conditions

Hodgkin's Disease Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Function Tests

Procedure

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

Procedure

Obtained at different time points during the study depending upon standard of care chemotherapy treatment

Primary outcomes

Pulmonary function

Time frame: 2 years

Changes in pulmonary function over time

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2005
Study completion: 2010
First posted: Sep 14, 2005
Registry last updated: Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed