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Support Care Cancer (2011) 19:833841
Received: 8 December 2009 /Accepted: 5 May 2010 /Published online: 25 May 2010
DOI 10.1007/s00520-010-0911-0
ORIGINAL ARTICLE
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 III &
John W. Kugler & Kay L. Hoff & Pavan S. Reddy & Kendrith M. Rowland Jr &
Mike Riepl & Bradley Christensen & Charles L. Loprinzi
# Springer-Verlag 2010
AbstractBackground 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
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.).
D. L. Barton (*) : R. Qin : B. Christensen : C. L. Loprinzi Mayo Clinic College of Medicine,200 First Street, SW,Rochester, MN, 55905 USAe-mail: [email protected]
E. J. WosMedcenter One Health System, Bismarck, ND, USA
B. I. Mattar : P. S. Reddy...