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
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2001
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 20, 2012
December 1, 2012
4.1 years
September 9, 2005
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary function
Changes in pulmonary function over time
2 years
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
Obtained at different time points during the study depending upon standard of care chemotherapy treatment
Eligibility Criteria
Patients with newly diagnosed classic Hodgkin's disease with mediastinal involvement in whom bleomycin-based chemotherapy alone or bleomycin-based chemotherapy and mediastinal irradiation are recommended as initial treatment.
You may qualify if:
- Patients with newly diagnosed classical Hodgkin's disease, with mediastinal involvement
- Bleomycin-based chemotherapy alone or in combination with mediastinal irradiation
You may not qualify if:
- Prior chest irradiation
- Mediastinal irradiation received at an outside institution
- Refractory or progressive disease on treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea K. Ng, MD, MPH
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
October 1, 2001
Primary Completion
November 1, 2005
Study Completion
January 1, 2010
Last Updated
December 20, 2012
Record last verified: 2012-12