TY - JOUR
T1 - A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy
T2 - NCCTG trial N06CA
AU - Barton, Debra L.
AU - Wos, Edward J.
AU - Qin, Rui
AU - Mattar, Bassam I.
AU - Green, Nathan Benjamin
AU - Lanier, Keith S.
AU - Bearden, James Dewitt
AU - Kugler, John W.
AU - Hoff, Kay L.
AU - Reddy, Pavan S.
AU - Rowland, Kendrith M.
AU - Riepl, Mike
AU - Christensen, Bradley
AU - Loprinzi, Charles L.
N1 - Funding 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.
PY - 2011/6
Y1 - 2011/6
N2 - 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.
AB - 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.
KW - BAK-PLO
KW - CIPN
KW - Topical gel
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U2 - 10.1007/s00520-010-0911-0
DO - 10.1007/s00520-010-0911-0
M3 - Article
C2 - 20496177
AN - SCOPUS:80051670484
SN - 0941-4355
VL - 19
SP - 833
EP - 841
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 6
ER -