Quality of Life Clinical Trial
Official title:
A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
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.
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.
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