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


Phase 3
16 Years
N/A
Not Enrolling
Both
Pulmonary Complications, Quality of Life, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven diagnosis of cancer
FEV-1/FVC at least 80% of predicted OR FEV-1/FVC less than 80% AND improvement in FEV-1
less than 15% after using a bronchodilator Maximum inspiratory pressure no greater than
-50 cm of water Oximetry at least 90% Rating of dyspnea "moderate" or "severe" on verbal
rating scale (VRS) of "none, mild, moderate, or severe" to describe "usual breathlessness"
when walking over the past 24 hours Score for pain of "none" or "mild" on a VRS of "none,
mild, moderate, or severe" for "unusual pain" over the past 24 hours

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life
expectancy: Greater than 10 days Hematopoietic: Hemoglobin at least 8.5 g/dL Hepatic:
AST/ALT no greater than 2 times upper limit of normal (ULN) No liver disease Renal:
Creatinine no greater than 2 times ULN No kidney disease Cardiovascular: No acute
congestive heart failure Greater than 3 months since prior myocardial infarction No
coronary artery disease where cardiac stimulation might prove harmful (i.e., no unstable
angina) No uncontrolled hypertension Pulmonary: See Disease Characteristics Other:
Folstein Mini-Mental Status Exam score of at least 24 Able (i.e., sufficiently fluent) and
willing to complete quality of life questionnaire and other assessments in either English
or French No history of clinically significant allergy or intolerance to theophylline,
aminophylline, or other methylxanthines No active peptic ulcer disease No uncontrolled
hyperthyroidism

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 14 days
since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 months
since prior initiation of hormonal therapy Hormones as appetite stimulant allowed if
received for more than 2 weeks No concurrent oral contraceptives Concurrent steroids
allowed if taken for at least 1 week prior to study Concurrent inhaled or oral
corticosteroids allowed if taken for at least 1 week prior to study No concurrent
initiation of a new hormonal manipulation Radiotherapy: At least 28 days since prior
radiotherapy that includes the lung in the treatment field No concurrent radiotherapy that
includes the lung in the treatment field Surgery: Not specified Other: No concurrent
digitalis glycosides, lithium, coumarin anticoagulants, other xanthines, cimetidine,
quinolone antibiotics (e.g, ciprofloxacin and norfloxacin), macrolide antibiotics (e.g.,
erythromycin), fluvoxamine, and calcium channel blockers Concurrent nebulized or inhaled
cromolyn, nedocromil, beta2-agonists, ipratropium, opioids, benzodiazepines, oxygen, and
diuretics allowed if dose is stable for more than 1 week prior to study No concurrent
paracentesis (i.e., thoracentesis) No concurrent blood transfusion

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Deborah J. Dudgeon, MD, RN

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Institute at Queen's University

Authority:

United States: Federal Government

Study ID:

SC14

NCT ID:

NCT00003684

Start Date:

March 1998

Completion Date:

December 2008

Related Keywords:

  • Pulmonary Complications
  • Quality of Life
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pulmonary complications
  • quality of life

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