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


N/A
18 Years
N/A
Not Enrolling
Both
Hodgkin's Disease

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Trial Information

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


- 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Pulmonary function

Outcome Description:

Changes in pulmonary function over time

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Andrea K. Ng, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

01-181

NCT ID:

NCT00165438

Start Date:

October 2001

Completion Date:

January 2010

Related Keywords:

  • Hodgkin's Disease
  • Pulmonary function
  • Bleomycin-based chemotherapy
  • mediastinal irradiation
  • Hodgkin Disease

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115