Journal Article

A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA

Qin, Rui, Reddy, Pavan S., Lanier, Keith S., Barton, Debra L., Mattar, Bassam I., Loprinzi, Charles L., Green, Nathan Benjamin, Kugler, John W., Riepl, Mike, Hoff, Kay L., Wos, Edward J., Rowland, Kendrith M., Christensen, Bradley, Bearden, James Dewitt

2011

Overview

Background Chemotherapy-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. Methods Patients 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. Results Data 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. Conclusion Topical 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.

• Publisher: Springer-Verlag,Springer,Springer Nature B.V
• Subject: Administration, Cutaneous / Adrenergic Uptake Inhibitors - administration & dosage / Adrenergic Uptake Inhibitors - adverse effects / Adrenergic Uptake Inhibitors - therapeutic use / Aged / Amitriptylene / Amitriptyline / Amitriptyline - administration & dosage / Amitriptyline - adverse effects / Amitriptyline - therapeutic use / Antineoplastic Agents - adverse effects / Baclofen / Baclofen - administration & dosage / Baclofen - adverse effects / Baclofen - therapeutic use / Burning / Cancer / Chemotherapy / Chronic pain / Clinical trials / Dosage / Double-Blind Method / Drug Combinations / Drug therapy / Excitatory Amino Acid Antagonists - administration & dosage / Excitatory Amino Acid Antagonists - adverse effects / Excitatory Amino Acid Antagonists - therapeutic use / Female / GABA-B Receptor Agonists - administration & dosage / GABA-B Receptor Agonists - adverse effects / GABA-B Receptor Agonists - therapeutic use / Gels / Humans / Ketamine / Ketamine - administration & dosage / Ketamine - adverse effects / Ketamine - therapeutic use / Lecithin / Lecithins - chemistry / Male / Measures / Medicine / Medicine & Public Health / Middle Aged / Neurological disorders / Nursing / Nursing Research / Oncology / Original Article / Pain / Pain Medicine / Patients / Peripheral Nervous System Diseases - chemically induced / Peripheral Nervous System Diseases - drug therapy / Peripheral neuropathy / Placebo effect / Poloxamer - chemistry / Rehabilitation Medicine / Shooting / Side effects / Treatment Outcome