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A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients (NCT00003684)

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.
  • Drug: theophylline
    • Procedure: quality-of-life assessment
      Ages eligible for Study
      16 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      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.

      4 locations

      Canada (4)
      • BC Cancer Agency
        Not specified
        Vancouver, British Columbia, Canada, V5Z 4E6
      • Kingston Regional Cancer Centre
        Not specified
        Kingston, Ontario, Canada, K7L 5P9
      • Algoma District Medical Group
        Not specified
        Sault Sainte Marie, Ontario, Canada, P6B 1Y5
      • Centre Hospitalier de l'Universite de Montreal
        Not specified
        Montreal, Quebec, Canada, H2W-W1T8
      28 February, 1998
      10 November, 2013
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