Yang, Y.H., Lin, J.K., Chen, W.S., Lin, T.C., Yang, S.H., Jiang, J.K., . . . Teng, H.W. (2012). Duloxetine improves oxaliplatin-induced neuropathy in patients with colorectal cancer: An open-label pilot study. Supportive Care in Cancer, 20, 1491-1497.

Evaluate the efficacy and tolerability of duloxetine in the treatment of chronic oxaliplatin-induced peripheral neuropathy

Patients receiving 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) who had grade 1-2 neuropathy on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) were given duloxetine at 30 mg/day and escalated to 60 mg/day for one week if there were no signs of drug intolerance. Patients were followed at two-week intervals for laboratory testing, assessment, and evaluation for adverse effects and symptom grading. The study lasted 12 weeks.

• N = 30
• MEAN AGE = 64.8 years (range = 34-83 years)
• MALES = 56.4%, FEMALES = 43.6%
• KEY DISEASE CHARACTERISTICS: All had colorectal cancer; 79.5% had stage IV disease.
• OTHER KEY SAMPLE CHARACTERISTICS: 43% had grade 1 neuropathy at baseline, and 54% had grade 2 at baseline.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Taiwan

PHASE OF CARE: Active antitumor treatment

Single-group, prospective, open-label trial

• Visual analog scale (VAS) for peripheral neuropathy pain (10 cm)
• NCI CTCAE v3.0

VAS scores showed improvement in 63.3% of patients who continued on the study for 12 weeks, and 47.4% maintained a stable grade of neuropathy. 28% discontinued duloxetine because of intolerable adverse events, including dizziness, nausea, somnolence, restlessness, insomnia, and urinary hesitancy. No substantive changes in serum creatinine or hepatic enzyme levels occurred.

For those patients who could tolerate escalating doses of duloxetine, it appeared to have some benefit in reducing peripheral neuropathy symptoms.

• Small sample of < 100
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Subject withdrawals ≥ 10%
• 30% withdrew due to inability to tolerate the medication.

Some antidepressants have been studied for their potential effect on chemotherapy-induced peripheral neuropathy. This study suggests that duloxetine may be helpful to some patients; however, the study was limited by a small sample size and open-label design. Thirty percent of the sample dropped out of the study within the first 12-week period due to side effects of the study medication, showing that many patients may not be able to tolerate the drug. Nurses caring for patients with or the potential for peripheral neuropathy symptoms and who are being treated with antidepressants need to assess for patient tolerance of these drugs. Further research is needed to establish the efficacy of antidepressants for peripheral neuropathy secondary to chemotherapy administration.