There are no known effective treatments for painful chemotherapy-induced peripheral
neuropathy.
To determine the effect of duloxetine, 60 mg daily, on average pain severity.
Randomized, double-blind, placebo-controlled crossover trial at 8 National Cancer
Institute (NCI)-funded cooperative research networks that enrolled 231 patients who
were 25 years or older being treated at community and academic settings between April
2008 and March 2011. Study follow-up was completed July 2012. Stratified by chemotherapeutic
drug and comorbid pain risk, patients were randomized to receive either duloxetine
followed by placebo or placebo followed by duloxetine. Eligibility required that patients
have grade 1 or higher sensory neuropathy according to the NCI Common Terminology
Criteria for Adverse Events and at least 4 on a scale of 0 to 10, representing average
chemotherapy-induced pain, after paclitaxel, other taxane, or oxaliplatin treatment.
The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine
or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo
daily for 4 additional weeks.
The primary hypothesis was that duloxetine would be more effective than placebo in
decreasing chemotherapy-induced peripheral neuropathic pain. Pain severity was assessed
using the Brief Pain Inventory-Short Form "average pain" item with 0 representing
no pain and 10 representing as bad as can be imagined.
Individuals receiving duloxetine as their initial 5-week treatment reported a mean
decrease in average pain of 1.06 (95% CI, 0.72-1.40) vs 0.34 (95% CI, 0.01-0.66) among
those who received placebo (P = .003; effect size, 0.513). The observed mean difference
in the average pain score between duloxetine and placebo was 0.73 (95% CI, 0.26-1.20).
Fifty-nine percent of those initially receiving duloxetine vs 38% of those initially
receiving placebo reported decreased pain of any amount.
Among patients with painful chemotherapy-induced peripheral neuropathy, the use of
duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain.
clinicaltrials.gov Identifier: NCT00489411.