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01.06.2011 | Original Article

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

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

Erschienen in: Supportive Care in Cancer | Ausgabe 6/2011

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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.

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Titel: A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA
verfasst von: Debra L. Barton
Edward J. Wos
Rui Qin
Bassam I. Mattar
Nathan Benjamin Green
Keith S. Lanier
James Dewitt Bearden III
John W. Kugler
Kay L. Hoff
Pavan S. Reddy
Kendrith M. Rowland Jr
Mike Riepl
Bradley Christensen
Charles L. Loprinzi
Publikationsdatum: 01.06.2011
Verlag: Springer-Verlag
Erschienen in: Supportive Care in Cancer / Ausgabe 6/2011
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-010-0911-0

Springer Medizin

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