• J. Clin. Oncol. · Aug 1997

    Randomized Controlled Trial Clinical Trial

    Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients.

    • N Ellison, C L Loprinzi, J Kugler, A K Hatfield, A Miser, J A Sloan, D B Wender, K M Rowland, R Molina, T L Cascino, A M Vukov, H S Dhaliwal, and C Ghosh.
    • Geisinger Clinical Oncology Program, Danville, PA, USA.
    • J. Clin. Oncol. 1997 Aug 1;15(8):2974-80.

    PurposeA minority of cancer survivors develops long-term postsurgical neuropathic pain. Based on evidence that capsaicin, the pungent ingredient in hot chili peppers, might be useful for treating neuropathic pain, we developed the present clinical trial.Patients And MethodsNinety-nine assessable patients with postsurgical neuropathic pain were entered onto this study. After stratification, patients were to receive 8 weeks of a 0.075% capsaicin cream followed by 8 weeks of an identical-appearing placebo cream, or vice versa. A capsaicin/placebo cream was to be applied to the painful site four times daily. Treatment evaluation was performed by patient-completed weekly questionnaires.ResultsDuring the first 8-week study period, the capsaicin-cream arm was associated with substantially more skin burning, skin redness, and coughing (P < .0001 for each). Nonetheless, treatment was stopped for patient refusal or toxicity just as often while patients were receiving the placebo as compared with the capsaicin. The capsaicin cream arm had substantially more pain relief (P = .01) after the first 8 weeks, with an average pain reduction of 53% versus 17%. On completion of the 16-week study period, patients were asked which treatment period was most beneficial. Of the responding patients, 60% chose the capsaicin arm, 18% chose the placebo arm, and 22% chose neither (P = .001).ConclusionA topical capsaicin cream decreases postsurgical neuropathic pain and, despite some toxicities, is preferred by patients over a placebo by a three-to-one margin among those expressing a preference.

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