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Patient
Selection
Adult inpatients
or outpatients will be recruited from the inpatient wards
and the ambulatory clinics. The patient's primary attending
physician will be informed of the plan to recruit the patient
into the study before the patient is contacted.
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Diagnosis
of cancer, with active disease.
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Patient
has received no primary antineoplastic therapy or the
most recent cancer therapy (chemotherapy, immunotherapy,
radiotherapy, or surgery) occurred at least two months
earlier.
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Patient
has a Karnofsky Performance Status score of >70 and has
a life expectancy of at least 3 months.
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Patient
is able to swallow and absorb oral medications.
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Medications
for other chronic disorders will be allowed as long as
doses have been stable for a minimum of three weeks and
no dose changes are anticipated during the duration of
the trial.
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Patients
with average daily fatigue of 5 or greater, as indicated
by the response to the following criterion question: "How
would you rate your fatigue, on average during the past
week, using a zero to 10 scale, where 0 is no fatigue
at all and 10 is the worst fatigue that you can imagine?"
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No
relative or absolute contraindications to treatment with
psychostimulant drugs, specifically cardiac arrhythmia
or other significant cardiac disease, severe anorexia,
severe insomnia, delirium or significant paranoid ideation.
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No
evidence of severe pulmonary, renal or hepatic disease;
serum creatinine and liver function tests must be no higher
than 2 times the upper limit of normal.
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No
evidence of acute or chronic encephalopathy or psychiatric
disease severe enough to compromise data collection.
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No
known allergy to modafinil.
Discussion:
The primary aim of the study is to evaluate the drug for chronic
cancer-related fatigue. Fatigue may be determined by many factors
in the cancer population and numerous options exist for entry
criteria into the study. This is a good illustration of the trade-offs
that must be considered. Suppose the aim was to clarify the effect
of the drug on fatigue related primarily to advanced cancer and
not to cancer therapy, depression, anemia, or any of the other
factors that could be etiologic in this population. Recruitment
would likely be very difficult. Instead, the decision has been
made to try to limit the impact of therapy (and to reduce the
likelihood of studying patients who are experiencing transitory
fatigue) by setting up an interval of at least two months from
the time of last antineoplastic therapy. This, in itself, is likely
to make recruitment far more difficult, but the risk is worth
taking for the chance to have a more homogeneous study population
and avoid the problem of transitory fatigue. The decision to include
patients with other etiologies for fatigue is less worrisome if
data about these potential etiologies and comorbidities are collected
during the study, thereby holding open the possibility that their
impact can be evaluated statistically.
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