A phase III study found that duloxetine (Cymbalta?, Eli Lilly), a serotonin-norepinephrine reuptake inhibitor anti-depressant, is effective in treating painful chemotherapy-induced peripheral neuropathy. This finding will likely change oncology practice and offers an important new quality of life solution for patients. Duloxetine is currently approved for the treatment of depression and painful diabetic peripheral neuropathy.

Painful peripheral neuropathy?numbness and tingling in the hands and feet?affects 20 to 30% of cancer patients treated with taxanes and platinum-based chemotherapy and can be very debilitating. There has been no known effective treatment for peripheral neuropathy, which can lower the quality of life of patients during treatment and sometimes last for years afterwards.

Not for every patient
?Duloxetine isn?t perfect and didn?t work for every patient in our study, but it was effective for a majority of people, and this was the first randomized clinical trial to show that any drug is effective for this terrible pain,? said lead study author Ellen M. Lavoie Smith, Ph.D., an assistant professor in the School of Nursing at University of Michigan, Ann Arbor, MI. ?We now have a treatment that could improve the quality of life for many of our patients.?

In the study, 231 patients who had previously reported high levels of pain from peripheral neuropathy due to taxane or platinum treatment were randomized to duloxetine followed by placebo versus placebo followed by duloxetine.

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?The participants took one 30mg capsule daily for one week, followed by two capsules daily (60mg total) for four additional weeks. The gradual dosing was important to reduce the side effects of duloxetine, which can include fatigue, dry mouth, sleepiness, and nausea,? Smith said.

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Patients completed a pain survey at the beginning of the study and then weekly. Results were as follows:
? Patients reporting decrease in pain: 59% for duloxetine, 39% for placebo.
? Patients reporting no change in pain: 30% for duloxetine, 33% for placebo.
? Patients reporting increase in pain: 11% for duloxetine, 28% for placebo.

The incidence of moderate to severe (grade 2 or greater) fatigue, the most commonly reported side effect, was higher in the duloxetine arm compared to placebo (11% vs. 3%).

Presentation: Tuesday, June 5, 2012, 9:45 ? 10:00 AM CDT
Abstract: #CRA9013
Title: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN).
Authors:Lavoie Smith EM, Pang H, Cirrincione C, Fleishman SB, Paskett ED, Fadul CE, et al.

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