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

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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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Authors and Affiliations

Authors

Corresponding author

Correspondence to Debra L. Barton.

Additional information

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-63848, CA-35195, CA-37417, CA-35448, CA-35267, CA-63849, CA-35113, CA-35103, CA-35415, CA-35431, and CA124477. The content is solely the responsibility of the authors and does not necessarily represent the views of the National Cancer Institute or the National Institute of Health.

Additional participating institutions include the following: Cedar Rapids Oncology Program CCOP, Cedar Rapids, IA 52403, USA (Martin Wiesenfeld, MD); Geisinger Clinic and Medical Center CCOP, Danville, PA 17822, USA (Albert M. Bernath, Jr., M.D.); Rapid City Regional Hospital, Inc, Rapid City, SD 57701, USA (Richard Charles Tenglin, M.D.); Sioux Community Cancer Consortium, Sioux Falls, SD 57105, USA (Loren K. Tschetter, M.D.); Toledo Community Hospital Oncology Program (Paul L. Schaefer, M.D.); Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, MN 55416, USA (Patrick J. Flynn, M.D.); Mayo Clinic, Scottsdale, AZ 85259-5404, USA (Tom R. Fitch, M.D.); and Hematology/Oncology Centers of the Northern Rockies, Billings, MT 59101, USA (Benjamin Marchello, M.D.).

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Barton, D.L., Wos, E.J., Qin, R. et al. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer 19, 833–841 (2011). https://doi.org/10.1007/s00520-010-0911-0

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