Theophylline in Treating Cancer Patients With Shortness of Breath
RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer. It is not yet known whether theophylline is more effective than no further treatment for shortness of breath.
PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in treating shortness of breath in patients who have cancer.
|Pulmonary Complications Quality of Life Unspecified Adult Solid Tumor, Protocol Specific||Drug: theophylline Procedure: quality-of-life assessment||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients|
|Study Start Date:||March 1998|
|Study Completion Date:||December 2008|
OBJECTIVES: I. Determine whether theophylline will improve the dyspnea rating of patients with cancer who are short of breath and have evidence of respiratory muscle weakness. II. Determine whether this drug will improve the ability to perform daily activities in this group of patients. III. Determine whether this drug will improve objective measures of lung function (e.g., FEV-1, FVC) and maximum inspiratory pressure in these patients. IV. Determine whether the serum theophylline level is related to the magnitude of the effect that is observed in this patient population. V. Determine whether this drug will improve a global rating of quality of life in this patient group.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to those who can complete a 6 minute walking test versus those who cannot. Patients receive either oral theophylline or placebo once daily for 3 days. In the absence of dose limiting toxicity (DLT), patients receive an increased dose for an additional 4 days. In the presence of DLT, patients receive a decreased dose or treatment is stopped. Following completion of the 7 day study period, patients may be given the option to continue on active drug or placebo for 1 additional month unless toxic side effects develop. Quality of life is assessed on days 1 and 8 and at the end of the additional 1 month period.
PROJECTED ACCRUAL: A total of 60 patients (30 in each arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003684
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Kingston Regional Cancer Centre|
|Kingston, Ontario, Canada, K7L 5P9|
|Algoma District Medical Group|
|Sault Sainte Marie, Ontario, Canada, P6B 1Y5|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2W-W1T8|
|Study Chair:||Deborah J. Dudgeon, MD, RN||Cancer Research Institute at Queen's University|