Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Jun;19(6):833-41.
doi: 10.1007/s00520-010-0911-0. Epub 2010 May 25.

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

Debra L Barton  1 , Edward J Wos, Rui Qin, Bassam I Mattar, Nathan Benjamin Green, Keith S Lanier, James Dewitt Bearden 3rd, John W Kugler, Kay L Hoff, Pavan S Reddy, Kendrith M Rowland Jr, Mike Riepl, Bradley Christensen, Charles L Loprinzi
Affiliations
Randomized Controlled Trial

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

Debra L Barton et al. Support Care Cancer. 2011 Jun.

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1. CONSORT diagram
Fig. 2
Fig. 2. Sensory subscale of the EORTC QLQ-CIPN-20; change from baseline, lower numbers are better
Fig. 3
Fig. 3. Motor subscale of the EORTC QLQ-CIPN-20; change from baseline, lower numbers are better
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Cavaletti G, Bogliun G, Marzorati L, et al. Peripheral neurotoxicity of Taxol in patients previously treated with cisplatin. Cancer. 1995;75:1141–1150. - PubMed
    1. Cavaletti G, Fabbrica D, Minoia C, et al. Carboplatin toxic effects on the peripheral nervous system of the rat. Ann Oncol. 1998;9:443–447. - PubMed
    1. Ocean JA, Vahdat LT. Chemotherapy-induced peripheral neuropathy: pathogenesis and emerging therapies. Support Care Cancer. 2004;12:619–625. - PubMed
    1. Pace A, Bove L, Aloe A, et al. Paclitaxel neurotoxicity: clinical andneurophysiological study of 23 patients. Ital JNeurol Sci. 1997;18:73–79. - PubMed
    1. Rowinsky EK, Chaudry V, Cornblath DR, et al. Neurotoxicity of taxol. J Natl Cancer Inst Monogr. 1993;15:107–115. - PubMed

Publication types

MeSH terms