• Debra L Barton, Edward J Wos, Rui Qin, Bassam I Mattar, Nathan Benjamin Green, Keith S Lanier, James Dewitt Bearden, John W Kugler, Kay L Hoff, Pavan S Reddy, Kendrith M Rowland, Mike Riepl, Bradley Christensen, and Charles L Loprinzi.
• Mayo Clinic College of Medicine, 200 First Street, SW, Rochester, MN 55905, USA. Barton.debra@mayo.edu
• Support Care Cancer. 2011 Jun 1;19(6):833-41.

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem.MethodsPatients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks.ResultsData in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p = 0.053) and motor subscales (p = 0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity.ConclusionTopical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN.

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