A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
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.
Allocation: Randomized, Primary Purpose: Supportive Care
Deborah J. Dudgeon, MD, RN
Cancer Research Institute at Queen's University
United States: Federal Government