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


CONCLUSIONS
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.
Barton
Debra L
DL
Mayo Clinic College of Medicine, 200 First Street, SW, Rochester, MN 55905, USA. Barton.debra@mayo.edu
Wos
Edward J
EJ
Qin
Rui
R
Mattar
Bassam I
BI
Green
Nathan Benjamin
NB
Lanier
Keith S
KS
Bearden
James Dewitt
JD
Kugler
John W
JW
Hoff
Kay L
KL
Reddy
Pavan S
PS
Rowland
Kendrith M
KM
Riepl
Mike
M
Christensen
Bradley
B
Loprinzi
Charles L
CL
D000279:Administration, Cutaneous; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000368:Aged; D000639:Amitriptyline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D058786:GABA-B Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005782:Gels; D006801:Humans; D007649:Ketamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D054709:Lecithins / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000188:drug therapy*; D020442:Poloxamer / Q000737:chemistry; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D000970:Antineoplastic Agents; D004338:Drug Combinations; D018691:Excitatory Amino Acid Antagonists; D058786:GABA-B Receptor Agonists; D005782:Gels; D054709:Lecithins; D020442:Poloxamer; D000639:Amitriptyline; D007649:Ketamine; D001418:Baclofen