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Annals of Oncology Advance Access published online on January 6, 2009
Annals of Oncology, doi:10.1093/annonc/mdn644
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB)

C. L. Loprinzi1,*, A. C. Dueck1, B. S. Khoyratty2, D. L. Barton1, S. Jafar3, K. M. Rowland, Jr4, P. J. Atherton1, G. W. Marsa5, W. H. Knutson6, J. D. Bearden, III7, L. Kottschade1 and T. R. Fitch8

1 Division of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester
2 Metro-Minnesota Community Clinical Oncology Program, St Louis Park
3 Michigan Cancer Research Consortium, Ann Arbor
4 Carle Cancer Center CCOP, Urbana
5 Toledo Community Hospital Oncology Program CCOP, Toledo
6 Duluth CCOP, Duluth, MN
7 Upstate Carolina CCOP, Spartanburg
8 Mayo Clinic Arizona, Scottsdale, USA

* Correspondence to: Dr C. L. Loprinzi, Division of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Tel: +1-507-284-8964; Fax: +1-507-284-1803; E-mail: cloprinzi{at}mayo.edu

Introduction: Hot flashes represent a significant problem in men undergoing androgen deprivation therapy.

Materials and methods: Via a prospective, double-blind, placebo-controlled clinical trial, men with hot flashes, on a stable androgen deprivation therapy program for prostate cancer, received a placebo or gabapentin at target doses of 300, 600, or 900 mg/day. Hot flash frequencies and severities were recorded daily during a baseline week and for 4 weeks while the patients took the study medication.

Results: In the 214 eligible patients who began the study drug on this trial, comparing the fourth treatment week to the baseline week, mean hot flash scores decreased in the placebo group by 4.1 units and in the three increasing dose gabapentin groups by, 3.2, 4.6, and 7.0 units. Comparing the three combined gabapentin arms to the placebo arm did not result in significant hot flash differences. Wilcoxon rank-sum P values for change in hot flash scores and frequencies after 4 weeks of treatment were 0.10 and 0.02, comparing the highest dose gabapentin arm to the placebo arm, respectively. The gabapentin was well tolerated in this trial.

Conclusion: These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.

hot flashes, men, prostate cancer

Received for publication July 2, 2008. Revision received August 26, 2008. Accepted for publication August 27, 2008.


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