PHASE-III PLACEBO-CONTROLLED TRIAL OF CAPSAICIN CREAM IN THE MANAGEMENT OF SURGICAL NEUROPATHIC PAIN IN CANCER-PATIENTS

Purpose: A minority of cancer survivors develops long-term postsurgica l neuropathic pain. Based on evidence that capsaicin, the pungent ingr edient in hot chili peppers, might be useful for treating neuropathic pain, we developed the present clinical trial. Patients and Methods: N inety-nine assessable patients with postsurgical neuropathic pain were entered onto this study. After stratification, patients were to recei ve 8 weeks of a 0.075% capsaicin cream followed by 8 weeks of an ident ical-appearing placebo cream, or vice versa. A capsaicin/placebo cream was to be applied to the painful site four times daily. Treatment eva luation was performed by patient-completed weekly questionnaires. Resu lts: During the first 8-week study period, the capsaicin-cream arm was associated with substantially more skin burning, skin redness, and co ughing (P < .0001 for each). Nonetheless, treatment was stopped for pa tient refusal or toxicity just as often while patients. were receiving the placebo as compared with the capsaicin. The capsaicin cream arm h ad substantially more pain relief (P = .01) after the first 8 weeks, w ith an average pain reduction of 53% versus 17%. On completion of the 16-week study period, patients were asked which treatment period was m ost beneficial, Of the responding patients, 60% chose the capsaicin ar m, 18% chose the placebo arm, and 22% chose neither (P = .001). Conclu sion: A topical capsaicin cream decreases postsurgical neuropathic pai n and, despite some toxicities, is preferred by patients over a placeb o by a three-to-one margin among those expressing a preference. (C) 19 97 by American Society of Clinical Oncology.