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

Support Care Cancer. 2011 Jun;19(6):833-41. doi: 10.1007/s00520-010-0911-0. Epub 2010 May 25.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Cutaneous
  • Adrenergic Uptake Inhibitors / administration & dosage
  • Adrenergic Uptake Inhibitors / adverse effects
  • Adrenergic Uptake Inhibitors / therapeutic use
  • Aged
  • Amitriptyline / administration & dosage
  • Amitriptyline / adverse effects
  • Amitriptyline / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Baclofen / administration & dosage
  • Baclofen / adverse effects
  • Baclofen / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • 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 / administration & dosage
  • Ketamine / adverse effects
  • Ketamine / therapeutic use*
  • Lecithins / chemistry
  • Male
  • Middle Aged
  • Peripheral Nervous System Diseases / chemically induced
  • Peripheral Nervous System Diseases / drug therapy*
  • Poloxamer / chemistry
  • Treatment Outcome


  • Adrenergic Uptake Inhibitors
  • Antineoplastic Agents
  • Drug Combinations
  • Excitatory Amino Acid Antagonists
  • GABA-B Receptor Agonists
  • Gels
  • Lecithins
  • Poloxamer
  • Amitriptyline
  • Ketamine
  • Baclofen