Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients

Phase 3 Completed 462 enrolled Gary Morrow National Cancer Institute (NCI) · collab

RandomizedParallel-groupTriple-blindSupportive care

Summary

RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Timeline

Start: 2007-10
Primary completion: 2013-09
Completion: 2013-11

Outcome

Missed primary endpoint

paper The KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference=-0.17, p=0.363). PMID 24531792 ↗

Publications

Gewandter JS, Mohile SG, Heckler CE, Ryan JL, Kirshner JJ, Flynn PJ, Hopkins JO, Morrow GR. A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors. Support Care Cancer. 2014 Jul;22(7):1807-14. doi: 10.1007/s00520-014-2158-7. Epub 2014 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amitriptyline	Small molecule	4 %	Topical
Subject	Ketamine	Small molecule	2 %	Topical