A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA
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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.
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.
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.
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.
KeywordsCIPN Topical gel BAK-PLO
- 12.Pujude-Lauraine E, Guastalla JP, Weber B et al (1997) Efficacy and safety of the combination of paclitaxel/carboplatin in patients with previously treated advanced ovarian carcinoma: a multicenter French Groupe des investigateurs Nationauz pour l'etude des cancers ovariens phase II study. Semin Oncol 24:S15-30–S15-35Google Scholar
- 16.Nikcevich DA, Grothey A, Sloan JA, Kugler JW, Silberstein PT, Dentchev T, Wender DB, Novotny PJ, Windschitl HE, Loprinzi CL (2008) Effect of intravenous calcium and magnesium (IV CaMg) on oxaliplatin-induced sensory neurotoxicity (sNT) in adjuvant colon cancer: results of the phase III placebo-controlled, double-blind NCCTG trial N04C7. J Clin Oncol 26:(abstr 4009)Google Scholar
- 26.Jones M (2000) Chronic neuropathic pain: pharmacological interventions in the new millennium. Int J Pharm Comp 4(1):6–15Google Scholar
- 35.Franek M, Vaculin S, Rokyta R (2004) GABAB receptor agonist baclofen has non-specific antinociceptive effect in the model of peripheral neuropathy in the rat. Pysiol Res 53:351–355Google Scholar
- 40.McNair DM, Loor M, Droppleman LF (2003) Profile of mood states manual. Multi-Health Systems, New YorkGoogle Scholar
- 42.Sloan JA, O'Fallon JR, Suman VJ et al (1998) Incorporating quality of life measurement into oncology clinical trials. Proc Am Stat Assoc 1998:282–287Google Scholar