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Modafinil Improves Mental Well-Being in Patients with Brain Cancer


Posted on: 06/23/2006

Modafinil Improves Mental Well-Being in Patients with Brain Cancer


Allison Gandey


June 14, 2006 (Atlanta) — A drug used to treat sleep disorders has been found to improve cognitive function, mood, and fatigue in patients with brain tumors. In a small study presented at the 42nd annual meeting of the American Society of Clinical Oncology, test scores in cognitive abilities improved by an average of 21%, mood improved by 35%, and fatigue improved by 47%. Modafinil (Provigil, Cephalon) was found to be generally well tolerated, with a low incidence of adverse events.


"Fatigue related to cancer and to cancer treatment are important issues—especially for patients,” Lori Minasian, MD, chief of the National Cancer Institute’s community oncology and prevention trials research group, says in a news release. Not affiliated with the present study, Dr. Minasian's group is also researching the potential of the drug in treating cancer-related fatigue. “Modafinil is one of the more innovative means of treating fatigue, since it works on the body’s central nervous system," she said.

"With progress in treating cancer comes a new and unique challenge—ensuring the long-term health and quality of life for the growing number of cancer survivors in this country," Patricia Ganz, MD, from the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles and moderator of a press briefing, told reporters.

Dr. Ganz says that while recent studies paint a stark picture of some of the long-term health problems faced by survivors, other research, such as the present study, suggest that quality of life can be ameliorated for both cancer survivors and those living with the disease.

Majority of Patients Showed Clinically Meaningful Improvements

The researchers looked at 30 patients with primary malignant disease or nonmalignant cerebral tumors. Most patients were diagnosed with severe attention, memory, and fatigue problems. All of the patients had received some combination of neurosurgery, radiation therapy, and chemotherapy treatments. Several were receiving chemotherapy while participating in the study.

The researchers conducted a double-blind dose-controlled randomization of 200 or 400 mg per day of modafinil in divided doses. The washout period for the study was 1 week, and the open-label extension was 8 weeks.

Patients were given neurological examinations at prespecified times, and brain magnetic resonance imaging was performed before, during, and after completion of the trial. Patient scores before they started taking modafinil were compared with their scores after they had been taking it for 2 to 3 months, and the majority of patients showed clinically meaningful improvements in all areas.

Neurobehavioral and Fatigue Outcome Measures
Variable
Baseline (Mean Standard Deviation)
8 Wks (Mean Standard Deviation)
P
Trail making A
35.5 s (16.0)
29.7 s (21.7)
.01
Trail making B
95.5 s (47.2)
68.0 s (36.5)
<.0001
Symbol digit modalities, oral
50.4 (15.3)
61.5 (22.7)
.0002
Symbol digit modalities, manual
44.3 (13.3)
54.2 (20.0)
<.0001
Verbal fluency
32.5 (15.9)
42.3 (15.6)
<.0001
Hamilton depression scale
17.8 (9.0)
10.4 (6.5)
<.0001
Fatigue severity scale
5.2 (1.4)
3.6 (1.5)
<.0001
Modified fatigue impact scale
50.2 (17.0)
30.5 (16.7)
<.0001
Visual analog fatigue scale
4.0 (2.4)
6.7 (2.6)
.0001

The researchers told the press that the site of the tumor or psychological factors were believed to be responsible for a lack of response to the drug in 3 patients.

The most common side effects were headache (42%), insomnia (26%), dizziness (23%), dry mouth (23%), and nausea (13%). These events were considered mild to moderate in severity and typically resolved after adjustments in dose and scheduling of medication.

"This study shows there is hope for people with brain cancer and that there are interventions that can improve their quality of life," lead author Thomas Kaleita, PhD, assistant professor of psychiatry at the University of California, Los Angeles told reporters.

He pointed out that the next step would be to determine long-term outcomes and to verify that modafinil does not create a tolerance or lose efficacy over time.

ASCO 42nd Annual Meeting: Abstract 1503. Presented June 5, 2006.



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