Effect of Duloxetine on Pain, Function, and Quality of Life Among Patients With Chemotherapy-Induced Painful Peripheral Neuropathy
- Study type
- Clinical trial
- Study name
- Alliance duloxetine CIPN
- Design
- Randomised, double-blind, placebo-controlled crossover trial in 8 cooperative research networks funded by the US National Cancer Institute (NCI)
- Sample size
- 231 patients
- Source
- JAMA · 2013
- Trial registration
- NCT00489411
In plain words
Some chemotherapy drugs, such as paclitaxel and oxaliplatin, can damage the nerves in the hands and feet and cause pain. In this study, taking duloxetine for 5 weeks reduced pain more than a placebo. 59% of patients who took duloxetine first reported less pain, compared with 38% in the placebo group. Be sure to talk to your own doctor about taking this medicine.
Key results
Treatment arms and regimens
During the first 5 weeks: 1 duloxetine 30 mg capsule daily in the first week, then 2 × 30 mg capsules daily (60 mg per day) for another 4 weeks; then crossover to placebo. Details of the washout period and the second period in the full text of the paper.
During the first 5 weeks: 1 placebo capsule daily in the first week, then 2 placebo capsules daily for another 4 weeks; then crossover to duloxetine. Details of the washout period and the second period in the full text of the paper.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients aged 25 years or older treated in community and academic centres between April 2008 and March 2011. Inclusion: grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) and average chemotherapy-induced pain of at least 4 on a 0 to 10 scale, after treatment with paclitaxel, other taxanes or oxaliplatin. Randomisation was stratified by chemotherapy drug and risk of comorbid pain.
Endpoints
The primary hypothesis was that duloxetine is more effective than placebo in reducing chemotherapy-induced peripheral neuropathic pain. Pain severity was measured with the "average pain" item of the Brief Pain Inventory short form (0 = no pain and 10 = worst pain imaginable). The title of the paper also refers to function and quality of life, but their results are not reported in the abstract.
Safety and side effects
Safety and adverse-event data are not reported in the abstract; see the full text of the paper.
Clinical significance and place in guidelines
According to the abstract, duloxetine was the first option to show a greater effect than placebo for chemotherapy-induced peripheral neuropathic pain in a randomised placebo-controlled trial, at a time when no effective treatment was known. However, the reduction in pain was modest (mean difference 0.73 on a 0 to 10 scale). The status of this drug in clinical guidelines and drug approvals should be checked separately, as it is not mentioned in the abstract.
Limitations
The abstract gives no information on adverse events, function and quality-of-life outcomes, the washout period or the results of the second crossover period. The observed effect was modest in size, and treatment follow-up reported in the abstract is only 5 weeks. The full text of the paper should be consulted for a complete assessment of limitations.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.