Breast Cancer Research and Treatment

, Volume 136, Issue 2, pp 479–486 | Cite as

A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors

  • Jill E. Lavigne
  • Charles Heckler
  • Jennifer L. Mathews
  • Oxana Palesh
  • Jeffrey J. Kirshner
  • Raymond Lord
  • Andrew Jacobs
  • Eric Amos
  • Gary R. Morrow
  • Karen Mustian
Clinical Trial

Abstract

Gabapentin is used for the treatment of hot flashes and neuropathic pain in breast cancer survivors, and is commonly used off-label for the treatment of anxiety. Yet, clinical trial evidence to support the use of gabapentin for anxiety symptoms is lacking. In a randomized, double-blinded controlled trial we compared 300 mg gabapentin versus 900 mg gabapentin versus placebo. Subjects were 420 breast cancer patients who had completed all chemotherapy cycles. Anxiety traits and current (state) anxiety were measured using the Speilberger Strait-Trait Anxiety Inventory at baseline, 4 and 8 weeks. Pain was measured at baseline using a 10-point scale. Analyses included analysis of covariance and ordinary least squares regression. At 4 weeks, state anxiety change scores were significantly better for gabapentin 300 and 900 mg (p = 0.005) compared to placebo. The magnitude of improvement was proportional to baseline state anxiety. At 8 weeks, the anxiolytic effects of gabapentin compared to placebo persisted (p < 0.005). We found no significant interactions. The lower dose (300 mg) was associated with the best treatment outcomes for all patients except those with the highest baseline anxiety. Given its similar pharmacology, efficacy in the treatment of hot flashes, and low cost, gabapentin may provide a low cost and parsimonious alternative treatment choice for breast cancer survivors presenting in primary care practices with anxiety symptoms. Gabapentin is effective for hot flashes, and, therefore, may provide therapeutic benefit for both anxiety and hot flashes at a generic drug price. For patients reluctant to take a controlled substance, such as a benzodiazepine, gabapentin may offer an alternative therapy. Similarly, patients with a history of substance use may benefit from gabapentin without risk of addiction or abuse. For cancer survivors experiencing both hot flashes and anxiety, gabapentin may provide a single effective treatment for both and is an alternative therapy for anxiety for patients unwilling to take a benzodiazepine or those with a history of substance use.

Keywords

Gabapentin Neurontin Anti-epileptics Breast Cancer Anxiety Randomized controlled trial Cancer survivorship 

Notes

Acknowledgments

The clinical trial was supported by the National Cancer Insitute. Gabpentin and placebo were provided by Pfizer. This secondary analysis was not supported by external funding.

Conflict of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer Science+Business Media, LLC. 2012

Authors and Affiliations

  • Jill E. Lavigne
    • 1
  • Charles Heckler
    • 2
  • Jennifer L. Mathews
    • 1
  • Oxana Palesh
    • 3
  • Jeffrey J. Kirshner
    • 4
  • Raymond Lord
    • 4
  • Andrew Jacobs
    • 4
  • Eric Amos
    • 1
  • Gary R. Morrow
    • 2
  • Karen Mustian
    • 2
  1. 1.Wegmans School of PharmacySt. John Fisher CollegeRochesterUSA
  2. 2.Department of Radiation OncologyJames P. Wilmot Cancer Center, University of Rochester Medical CenterRochesterUSA
  3. 3.Department of PsychiatryStanford University Medical SchoolPalo AltoUSA
  4. 4.Community Clinical Oncology BaseJames P. Wilmot Cancer Center, University of Rochester Medical CenterRochesterUSA

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