By Ed Susman, United Press International
June 7, 2006
Provigil useful in battle with brain cancer
ATLANTA -- A drug often prescribed to help people overcome drowsiness
caused by shift work or other conditions appears to improve depression,
fatigue and difficulty in maintaining attention to the activities of daily
living that often accompanies people battling brain cancer.
While most cancers that arise in the brain are incurable and are difficult
to treat, recent advances with precise surgery, new drugs and devices
that actually can be placed in the brain to combat the disease have lengthened
survival considerably for people with these diseases.
At this week's American Society of Clinical Oncology meeting, researchers
described how they markedly improved quality of life of patients by administering
modafinil -- sold as Cephalon's Provigil -- a drug primarily used to treat
patients with narcolepsy -- a condition in which people suddenly fall
asleep at inappropriate times, and the lethargy that accompanies people
who work odd hours.
"We were able to see clinically meaningful outcomes in this trial,"
said Thomas Kaleita, assistant professor of psychiatry at the University
of California, Los Angeles. In his trial of 30 individuals -- 19 men and
11 women -- statistically significant improvement was seen in tests of
mental acuity, in measurements of depression and in tests of fatigue.
"The improvements that were seen in this trial were huge,"
said Jeff Sloan, a researcher in oncology at the Mayo Clinic Comprehensive
Cancer Center in Rochester, Minn.
Sloan, who commented on the study at the ASCO meeting, said that the
effect of the treatments were likely to make meaningful differences in
the lives of the patients. The study was among hundreds presented to the
25,000 health care professionals attending the sessions in Atlanta.
"This is very encouraging study," Suzan Streichenwein, a psychiatrist
based in West Palm Beach, Fla., told United Press International. "Oncologists
are concerned about quantity of life but equally important is the quality
of life." She said that often, these patients are so sluggish due
to their medications and disease, they can barely move around.
In the study, Kaleita administered several psychological tests to the
patients. The patients took between 50 milligrams of modafinil and 600
mg a day. He said he saw across-the-board improvement. Cognitive abilities
increased 21 percent, mood improved by 35 percent, fatigue improved by
47 percent and depression improved 43 percent.
All the changes from the start of the trial through 12 weeks of the
study proved to be highly statistically significant.
For example, in one test of fatigue levels, patients were asked to measure
their fatigue on a 0 to 10 scale with 10 representing extreme fatigue.
They averaged a score of "4" -- or moderate fatigue -- when
they began the test. After 10 weeks of modafinil, their average fatigue
scores dropped by 3 points, indicating a 75 decline in fatigue, and after
12 weeks, there was an 83 percent decline in scores.
Sloan said those fatigue scores really represent more than a doubling
in how well a patient feels, recognizing that this improvement occurred
even while the patient was struggling with brain cancer.
"The improvements with this drug are important," said Streichenwein,
but she cautioned that some dosages of modafinil used in the study are
above that normally prescribed for depression, and added that the drug
is expensive.
Sloan said the studies show there is a complex, complicated system involved
in brain cancer and that fatigue plays a major role in a patient's well
being.
"This study shows there is hope for people with brain cancer, and
that there are interventions that can improve quality of life," Kaleita
said.
Provigil for cancer patients.
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