By Tehreem Khan
Duloxetine, a medication commonly used to treat chronic pain and psychiatric conditions, does not prevent nerve damage caused by chemotherapy in patients with colorectal cancer, a randomized trial conducted by a researcher at the University of Alabama at Birmingham School of Nursing found.
Oxaliplatin is a standard chemotherapy drug used to treat colorectal cancer; but it can often lead to peripheral neuropathy, a sometimes-permanent side effect that causes numbness, tingling and pain in the hands and feet.
Duloxetine, often prescribed for chronically painful conditions such as osteoarthritis and diabetic neuropathy and psychological conditions like anxiety and depression, is already recommended for the treatment of established painful chemotherapy-induced peripheral neuropathy.
“Since we know duloxetine is effective at treating painful neuropathy caused by neurotoxic chemotherapy drugs, we wanted to see if the medication could also prevent the side effect from developing in the first place,” said Professor, Interim Associate Dean for Research and Scholarship and Marie O’Koren Endowed Chair in Nursing Ellen M. Lavoie Smith, PhD, RN, AOCN, FAAN, who is study chair for Alliance for Clinical Trials in OncologyOpens an external link.. “The results show that duloxetine is not more effective than a placebo at preventing neuropathy caused by chemotherapy in patients with colorectal cancer.”
Led by Smith, this is the largest randomized trial to date specifically designed to evaluate whether duloxetine can prevent oxaliplatin induced peripheral neuropathy.
In the double blind, placebo controlled trial, 199 adults with stage II or III colorectal cancer were enrolled at 73 cancer centers throughout the United States. Participants had no preexisting neuropathy and were randomly assigned to receive duloxetine 30 mg daily, duloxetine 60 mg daily or a placebo.
Treatment began on the first day of oxaliplatin based chemotherapy and continued for 17 weeks. The primary endpoint was a patient reported composite measure of neuropathy severity and onset, assessed several weeks after completion of chemotherapy. Results showed no meaningful difference between either duloxetine dose or placebo.
“While duloxetine remains an important option for managing painful chemotherapy induced neuropathy once it develops, this trial confirms that it should not be used for prevention,” Smith said.