Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Summary

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Timeline

Start

2008-04

Primary completion

2012-01

Completion

2013-03

Outcome

Met primary endpoint

paper Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain. PMID 23549581 ↗

registry p = 0.003; Mean Difference 0.73 (95% CI 0.26 to 1.20); Wilcoxon (Mann-Whitney) NCT00489411 ↗

Publications

• Results Lavoie Smith EM, Pang H, Cirrincione C, et al.: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). [Abstract] J Clin Oncol 30 (Suppl 15): A-CRA9013, 2012.
• Smith EM, Pang H, Ye C, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Le-Lindqwister N, Fadul CE, Loprinzi C, Shapiro CL; Alliance for Clinical Trials in Oncology. Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial - CALGB/alliance 170601. Eur J Cancer Care (Engl). 2017 Mar;26(2):10.1111/ecc.12421. doi: 10.1111/ecc.12421. Epub 2015 Nov 25.
• Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	Oral

Indications