PURPOSE:
BACKGROUND:
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Malignant pleural effusions occur commonly in the terminal stages of patients with malignant disease. Approximately 50% of patients with cancer eventually develop pleural effusion causing symptoms of dyspnea, cough and chest pain.
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This study showed a high failure of complete lung reexpansion before the administration of talc as well as a high mortality within the first 30 days related to interventions that are minimally invasive, require minimal patient confinement, and are effective in controlling dyspnea caused effusion related lung displacement.
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The small catheter method has the advantage of not requiring inpatient hospitalization and avoiding the pain and associated complications caused by pleurodesis. Its downsides include a longer time until pleurodesis occurs and possible increased nutritional loss that can occur with ongoing pleural fluid drainage.
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Anecdotally, its use is expanding at cancer centers without a lot of controlled investigational data to support its effectiveness as compared to other accepted therapies. If this study shows equivalence or superiority of small catheter drainage it would support the trend toward less invasive, outpatient management. If negative, or if there is similar control of dispend and adverse QOL problems, then physicians will be justified in offering either treatment arm as safe alternatives.
CRITERIA FOR INCLUSION OF SUBJECTS:
- Radiologic evidence of a unilateral effusion requiring sclerosis or ongoing drainage due to symptoms (dyspnea and /or progressive fatigue).
- No prior intrapleural therapy.
- Patient with history of histologically proven malignancy, ECOG performance status 0-2.
- No active pleural infection, allergy to talc, or other contraindication to talc usage, non-pregnant and non-nursing and age greater or equal to 18 years, required initial laboratory data includes granulocytes greater or equal to 1,500/ul and platelet count greater or equal to 100,000/ul.
CRITERIA FOR EXCLUSION OF SUBJECTS:
- Anticipated survival of less than 60 days, psychiatric illness which could interfere with patient’s ability to give informed consent, medical conditions, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient.
- Patients with a “currently active” second malignancy other than non-melanoma skin cancer.
- Patients that are not considered to have a “currently active” malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
RECRUITMENT OF SUBJECTS:
For more information, please contact Nicklett Johnston, R.N. at 214-645-7728.
