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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00165438
Enrollment
60
Registered
2005-09-14
Start date
2001-10-31
Completion date
2010-01-31
Last updated
2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Disease

Keywords

Pulmonary function, Bleomycin-based chemotherapy, mediastinal irradiation

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.

Interventions

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

PROCEDURECAT Scan

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

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary function2 yearsChanges in pulmonary function over time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026