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

Neil Ellison, Charles Lawrence Loprinzi, John Kugler, Alan K. Hatfield, Angela Miser, Jeff A Sloan, Donald B. Wender, Kendrith M. Rowland, Roy Molina, Terrence L. Cascino, Allen M. Vukov, Harbhajan S. Dhaliwal, Chirantan Ghosh

Research output: Contribution to journalArticle

129 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2974-2980
Number of pages7
JournalJournal of Clinical Oncology
Volume15
Issue number8
StatePublished - Aug 1997

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Capsaicin
Neuralgia
Placebos
Neoplasms
Capsicum
Pain
Skin
Survivors
Therapeutics
Clinical Trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients. / Ellison, Neil; Loprinzi, Charles Lawrence; Kugler, John; Hatfield, Alan K.; Miser, Angela; Sloan, Jeff A; Wender, Donald B.; Rowland, Kendrith M.; Molina, Roy; Cascino, Terrence L.; Vukov, Allen M.; Dhaliwal, Harbhajan S.; Ghosh, Chirantan.

In: Journal of Clinical Oncology, Vol. 15, No. 8, 08.1997, p. 2974-2980.

Research output: Contribution to journalArticle

Ellison, N, Loprinzi, CL, Kugler, J, Hatfield, AK, Miser, A, Sloan, JA, Wender, DB, Rowland, KM, Molina, R, Cascino, TL, Vukov, AM, Dhaliwal, HS & Ghosh, C 1997, 'Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients', Journal of Clinical Oncology, vol. 15, no. 8, pp. 2974-2980.
Ellison, Neil ; Loprinzi, Charles Lawrence ; Kugler, John ; Hatfield, Alan K. ; Miser, Angela ; Sloan, Jeff A ; Wender, Donald B. ; Rowland, Kendrith M. ; Molina, Roy ; Cascino, Terrence L. ; Vukov, Allen M. ; Dhaliwal, Harbhajan S. ; Ghosh, Chirantan. / Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 8. pp. 2974-2980.
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abstract = "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.",
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T1 - Phase III placebo-controlled trial of capsaicin cream in the management of surgical neuropathic pain in cancer patients

AU - Ellison, Neil

AU - Loprinzi, Charles Lawrence

AU - Kugler, John

AU - Hatfield, Alan K.

AU - Miser, Angela

AU - Sloan, Jeff A

AU - Wender, Donald B.

AU - Rowland, Kendrith M.

AU - Molina, Roy

AU - Cascino, Terrence L.

AU - Vukov, Allen M.

AU - Dhaliwal, Harbhajan S.

AU - Ghosh, Chirantan

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N2 - 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.

AB - 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.

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