Duloxetine improves oxaliplatin-induced neuropathy in patients with colorectal cancer: an open-label pilot study

Support Care Cancer. 2012 Jul;20(7):1491-7. doi: 10.1007/s00520-011-1237-2. Epub 2011 Aug 4.


Background: This open-label pilot study is aimed to evaluate the efficacy and tolerability of the antidepressant duloxetine, which is effective for diabetic neuropathic pain, in the treatment of chronic oxaliplatin-induced peripheral neuropathy (OIPN).

Methods: We enrolled a total of 39 patients with stage III or IV colorectal cancer with chronic OIPN. They were treated with duloxetine by increasing the dose from 30 mg/day to 60 mg/day. Patients' pain intensity was rated at baseline and 12 weeks after duloxetine administration. The severity of neuropathic pain was evaluated using the visual analog scale (VAS) score and the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3 (NCI-CTCAE v3.0).

Results: Nine patients (23.1%) discontinued duloxetine before the end of treatment because of adverse events. Of the remaining 30 patients, 19 patients (63.3%) had a VAS score improvement. Among them, nine (47.4%) showed a simultaneous grade improvement, and the other 10 patients (52.6%) had a stable grade according to NCI-CTCAE v3.0. Treatment with duloxetine did not impair renal or liver function and did not interfere with chemotherapy.

Conclusions: Duloxetine is feasible in treating chronic OIPN with tolerable toxicity at a daily dose of 60 mg/day.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Colorectal Neoplasms / drug therapy
  • Duloxetine Hydrochloride
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Organoplatinum Compounds / adverse effects*
  • Organoplatinum Compounds / therapeutic use
  • Oxaliplatin
  • Pain Measurement
  • Peripheral Nervous System Diseases / chemically induced
  • Peripheral Nervous System Diseases / drug therapy*
  • Pilot Projects
  • Severity of Illness Index
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*


  • Antidepressive Agents
  • Antineoplastic Agents
  • Organoplatinum Compounds
  • Thiophenes
  • Oxaliplatin
  • Duloxetine Hydrochloride