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

NCT ID: NCT00165438

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-31

Study Completion Date

2010-01-31

Brief Summary

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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

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* 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.

Conditions

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Hodgkin's Disease

Keywords

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Pulmonary function Bleomycin-based chemotherapy mediastinal irradiation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

CAT Scan

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Andrea K. Ng, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea K. Ng, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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01-181

Identifier Type: -

Identifier Source: org_study_id