Journal of Clinical Oncology, Vol 20, Issue 6
(March), 2002: 1578-1583
© 2002 American Society for Clinical Oncology
Phase III Evaluation of Fluoxetine for Treatment of Hot Flashes
By Charles L. Loprinzi,
Jeff A. Sloan,
Edith A. Perez,
Susan K. Quella,
Phillip J. Stella,
James A. Mailliard,
Michele Y. Halyard,
Sandhya Pruthi,
Paul J. Novotny,
Teresa A. Rummans
Mayo Clinic and Foundation, Rochester, MN; Mayo Clinic and Foundation, Jacksonville, FL; McAuley Cancer Care Center, Ann Arbor, MI; Creighton Cancer Center, Omaha, NE; and Mayo Clinic and Foundation, Scottsdale, AZ.
Address reprint requests to Charles L. Loprinzi, MD, Division of Medical Oncology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; email: cloprinzi{at}mayo.edu
PURPOSE: Hot flashes can be a prominent problem in women with a history of breast cancer. Given concerns regarding the use of hormonal therapies in such patients, other nonhormonal means for treating hot flashes are required. Based on anecdotal information regarding the efficacy of fluoxetine and other newer antidepressants for treating hot flashes, the present trial was developed.
PATIENTS AND METHODS: This trial used a double-blinded, randomized, two-period (4 weeks per period), cross-over methodology to study the efficacy of fluoxetine (20 mg/d) for treating hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen (because of breast cancer risk). Eligible patients had to have reported that they averaged at least 14 hot flashes per week; they could have received tamoxifen or raloxifene as long as they were on a stable dose. The major outcome measure was a bivariate construct representing hot flash frequency and hot flash score, analyzed by a classic sums and differences cross-over analysis.
RESULTS: Eighty-one randomized women began protocol therapy. By the end of the first treatment period, hot flash scores (frequency x average severity) decreased 50% in the fluoxetine arm versus 36% in the placebo arm. Cross-over analysis demonstrated a significantly greater marked hot flash score improvement with fluoxetine than placebo (P = .02). The results were not adjusted for potential confounding influences, including age and tamoxifen use. The fluoxetine was well tolerated.
CONCLUSION: This dose of fluoxetine resulted in a modest improvement in hot flashes.
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(2008)
mdn353v2.
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[PDF]
|
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|

|
 |

|
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|
 |
|

|
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|
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|
 |
|

|
 |

|
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|
 |
|

|
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|
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Journal of Pharmacy Practice,
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20(5):
385 - 391.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
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109(4):
823 - 830.
[Abstract]
[Full Text]
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|
 |
|

|
 |

|
 |
 
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Venlafaxine is superior to clonidine as treatment of hot flashes in breast cancer patients--a double-blind, randomized study
Ann. Onc.,
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18(4):
689 - 693.
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[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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March 1, 2007;
148(3):
1376 - 1383.
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[Full Text]
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|
 |
|

|
 |

|
 |
 
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J. Clin. Oncol.,
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25(3):
308 - 312.
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[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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November 30, 2006;
355(22):
2338 - 2347.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. Sestak, R. Kealy, R. Edwards, J. Forbes, and J. Cuzick
Influence of Hormone Replacement Therapy on Tamoxifen-Induced Vasomotor Symptoms
J. Clin. Oncol.,
August 20, 2006;
24(24):
3991 - 3996.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. H. Boekhout, J. H. Beijnen, and J. H.M. Schellens
Symptoms and treatment in cancer therapy-induced early menopause.
Oncologist,
June 1, 2006;
11(6):
641 - 654.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis.
JAMA,
May 3, 2006;
295(17):
2057 - 2071.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Pharmacogenetics of Tamoxifen Biotransformation Is Associated With Clinical Outcomes of Efficacy and Hot Flashes
J. Clin. Oncol.,
December 20, 2005;
23(36):
9312 - 9318.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Paroxetine Is an Effective Treatment for Hot Flashes: Results From a Prospective Randomized Clinical Trial
J. Clin. Oncol.,
October 1, 2005;
23(28):
6919 - 6930.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
W. L. Wolfman
HRT and antidepressants
Can. Med. Assoc. J.,
August 2, 2005;
173(3):
237 - 237.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Obstet. Gynecol.,
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105(5):
1137 - 1139.
[Full Text]
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|
 |
|

|
 |

|
 |
 
J. A. Schlechte
Update in Endocrinology
Ann Intern Med,
January 18, 2005;
142(2):
126 - 131.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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CYP2D6 Genotype, Antidepressant Use, and Tamoxifen Metabolism During Adjuvant Breast Cancer Treatment
J Natl Cancer Inst,
January 5, 2005;
97(1):
30 - 39.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Management of Postmenopausal Hot Flushes With Venlafaxine Hydrochloride: A Randomized, Controlled Trial
Obstet. Gynecol.,
January 1, 2005;
105(1):
161 - 166.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Obstet. Gynecol.,
October 1, 2004;
104(4_suppl):
106S - 117S.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Selective Serotonin-Reuptake Inhibitors for the Treatment of Hot Flashes
Ann. Pharmacother.,
July 1, 2004;
38(7):
1293 - 1296.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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A Hot Flash on Tamoxifen Metabolism
J Natl Cancer Inst,
December 3, 2003;
95(23):
1734 - 1735.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Active Tamoxifen Metabolite Plasma Concentrations After Coadministration of Tamoxifen and the Selective Serotonin Reuptake Inhibitor Paroxetine
J Natl Cancer Inst,
December 3, 2003;
95(23):
1758 - 1764.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. E Schober and N. T Ansani
Venlafaxine Hydrochloride for the Treatment of Hot Flashes
Ann. Pharmacother.,
November 1, 2003;
37(11):
1703 - 1707.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Andropause: Symptom Management for Prostate Cancer Patients Treated With Hormonal Ablation
Oncologist,
October 1, 2003;
8(5):
474 - 487.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
V. Stearns, K. L. Beebe, M. Iyengar, and E. Dube
Paroxetine Controlled Release in the Treatment of Menopausal Hot Flashes: A Randomized Controlled Trial
JAMA,
June 4, 2003;
289(21):
2827 - 2834.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. E. Piersen
Phytoestrogens in Botanical Dietary Supplements: Implications for Cancer
Integr Cancer Ther,
June 1, 2003;
2(2):
120 - 138.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Y. El-Ibiary and K. C. Lee
Novel Uses of Selective Serotonin Reuptake Inhibitors in Women
Journal of Pharmacy Practice,
June 1, 2003;
16(3):
191 - 199.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
H. Kattlove and R. J. Winn
Ongoing Care of Patients After Primary Treatment for Their Cancer
CA Cancer J Clin,
May 1, 2003;
53(3):
172 - 196.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Rosack
Antidepressants Reduce Hot Flashes, May Be Estrogen Alternative
Psychiatr News,
April 5, 2002;
37(7):
29 - 29.
[Full Text]
|
 |
|

|
 |

|
 |
 
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Cooling Off Hot Flashes
J. Clin. Oncol.,
March 15, 2002;
20(6):
1436 - 1438.
[Full Text]
[PDF]
|
 |
|
|