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Clinical Trials/NCT00165438
NCT00165438CompletedNot Applicable

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

Dana-Farber Cancer Institute2 sites in 1 country60 target enrollmentStarted: October 2001Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Pulmonary function
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Pulmonary function

Time Frame: 2 years

Changes in pulmonary function over time

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea K. Ng, MD

Principal Investigator

Dana-Farber Cancer Institute

Study Sites (2)

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