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

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, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

128 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)833-841
Number of pages9
JournalSupportive Care in Cancer
Volume19
Issue number6
DOIs
StatePublished - Jun 2011

Fingerprint

Peripheral Nervous System Diseases
Placebos
Drug Therapy
Therapeutics
Gels
Poloxamer
Pain
Baclofen
Amitriptyline
Hypesthesia
Lecithins
Ketamine
Arm
Randomized Controlled Trials
Hand
Research

Keywords

  • BAK-PLO
  • CIPN
  • Topical gel

ASJC Scopus subject areas

  • Oncology
  • Medicine(all)

Cite this

A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy : NCCTG trial N06CA. / Barton, Debra L.; Wos, Edward J.; Qin, Rui; Mattar, Bassam I.; Green, Nathan Benjamin; Lanier, Keith S.; Bearden, James Dewitt; Kugler, John W.; Hoff, Kay L.; Reddy, Pavan S.; Rowland, Kendrith M.; Riepl, Mike; Christensen, Bradley; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, Vol. 19, No. 6, 06.2011, p. 833-841.

Research output: Contribution to journalArticle

Barton, DL, Wos, EJ, Qin, R, Mattar, BI, Green, NB, Lanier, KS, Bearden, JD, Kugler, JW, Hoff, KL, Reddy, PS, Rowland, KM, Riepl, M, Christensen, B & Loprinzi, CL 2011, 'A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA', Supportive Care in Cancer, vol. 19, no. 6, pp. 833-841. https://doi.org/10.1007/s00520-010-0911-0
Barton, Debra L. ; Wos, Edward J. ; Qin, Rui ; Mattar, Bassam I. ; Green, Nathan Benjamin ; Lanier, Keith S. ; Bearden, James Dewitt ; Kugler, John W. ; Hoff, Kay L. ; Reddy, Pavan S. ; Rowland, Kendrith M. ; Riepl, Mike ; Christensen, Bradley ; Loprinzi, Charles Lawrence. / A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy : NCCTG trial N06CA. In: Supportive Care in Cancer. 2011 ; Vol. 19, No. 6. pp. 833-841.
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AU - Bearden, James Dewitt

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