Journal of Clinical Oncology, Vol 15, 2974-2980, Copyright © 1997 by American Society of Clinical Oncology
Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients
N Ellison, CL Loprinzi, J Kugler, AK Hatfield, A Miser, JA Sloan, DB Wender, KM Rowland, R Molina, TL Cascino, AM Vukov, HS Dhaliwal and C Ghosh
Geisinger Clinical Oncology Program, Danville, PA, USA.
PURPOSE: A 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 METHODS: Ninety-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. RESULTS: During 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). CONCLUSION: A 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.
