Treating Pain from Chemotherapy-Induced Peripheral Neuropathy
Name of the Trial
Phase III Randomized Study of Duloxetine Hydrochloride in Cancer Patients with Painful Chemotherapy-Induced Peripheral Neuropathy (CALGB-170601). See the protocol summary.
Dr. Ellen Smith and Dr. Richard Schilsky, Cancer and Leukemia Group B
Why This Trial Is Important
Chemotherapy has been a mainstay of cancer treatment for more than 50 years. Despite advances in chemotherapy drugs and their administration, however, many patients still experience distressing side effects related to treatment.
One chemotherapy-induced side effect that reduces the quality of life for many patients treated with drugs such as paclitaxel (Taxol) or oxaliplatin (Eloxatin) is peripheral neuropathy. This side effect develops when anticancer drugs damage nerve cells of the peripheral nervous system (the nerves beyond the brain and spinal cord). Patients with peripheral neuropathy may experience pain, tingling, numbness, or other uncomfortable sensations, usually beginning in their feet and/or hands. These feelings may get worse over time and affect more parts of the body (ankles, legs, arms).
The drug duloxetine (Cymbalta) has been shown to relieve pain associated with peripheral neuropathy caused by diabetes. Duloxetine helps maintain levels of the neurotransmitters serotonin and norepinephrine in the central nervous system (which includes the nerves in the brain and spinal cord). These neurotransmitters help prevent painful sensations from reaching the brain. Scientists want to know if duloxetine can also effectively treat pain from chemotherapy-induced peripheral neuropathy.
In this trial, patients with painful peripheral neuropathy caused by prior treatment with paclitaxel or oxaliplatin will be randomly assigned to receive either duloxetine or placebo pills for 6 weeks. All patients will then have a week without treatment (called a washout period), followed by a 6-week crossover period in which patients who received duloxetine initially will be given the placebo while those initially assigned to placebo will be given duloxetine. Neither the patients nor their health care providers will know who is receiving duloxetine or the placebo at any given time until after the study is over. Patients will complete pain and quality-of-life questionnaires weekly throughout the study.
“Neuropathic pain is different and often harder to treat than other types of pain,” said Dr. Smith. “There is a lot less known about the effects of various drugs on neuropathic pain.
“To date, several medications have been discovered to be helpful, but none has been able to fully alleviate the pain associated with chemotherapy-induced neuropathy,” she continued. “So we will likely need to develop an approach employing several drugs that work in different ways in hopes of creating a synergistic effect. Duloxetine may have a place in such an approach.”