Levetiracetam for the treatment of hot flashes: A phase II study

Supportive Care in Cancer

Volumn 16, Issue 1, 2008, Pages 75-82

  Thompson, Susan ^a   Bardia, Aditya ^a   Tan, Angelina ^a   Barton, Debra L ^a   Kottschade, Lisa ^a   Sloan, Jeff A ^a   Christensen, Brad ^a   Smith, Deanne ^a   Loprinzi, Charles L ^a  

^a MAYO CLINIC   (United States)

Author keywords

Hot flashes; Levetiracetam; Therapy

Indexed keywords

ETIRACETAM; PLACEBO;

ADULT; AGITATION; ARTHRALGIA; ARTICLE; ATAXIA; BREAST CANCER; CANCER SURVIVOR; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DEPRESSION; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DROWSINESS; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HOT FLUSH; HUMAN; INSOMNIA; NAUSEA; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RASH; SENSORY DYSFUNCTION; SIDE EFFECT; SOMNOLENCE; SWEAT GLAND DISEASE; VOMITING;

BREAST NEOPLASMS; DIZZINESS; FATIGUE; FEMALE; HOT FLASHES; HUMANS; MIDDLE AGED; NOOTROPIC AGENTS; PATIENT SATISFACTION; PILOT PROJECTS; PIRACETAM; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SLEEP STAGES;

EID: 36949014288     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00520-007-0276-1     Document Type: Article

References (72)

1. Abou-Khalil B (2005) Benefit-risk assessment of levetiracetam in the treatment of partial seizures. Drug Safety 28:871-890 (Review)
2. Baker F, Denniston M, Zabora J, Polland A, Dudley WN (2002) A POMS short form for cancer patients: psychometric and structural evaluation. Psychooncology 11:273-281
3. Barton DL, Loprinzi CL, Novotny P, Shanafelt T, Sloan J, Wahner-Roedler D, Rummans TA, Christensen B, Dakhill SR, Martin LS (2003) Pilot evaluation of citalopram for the relief of hot flashes. J Support Oncol 1:47-51
4. Barton DL, Loprinzi CL, Quella SK et al (1998) Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. J Clin Oncol 16:495-500
5. Bergkvist L, Adami HO, Persson I, Hoover R, Schairer C (1989) The risk of breast cancer after estrogen and estrogen-progestin replacement. N Engl J Med 321:293-297
6. Carpenter JS (2005) Physiological monitor for assessing hot flashes. Clin Nurse Spec 19:8-10
7. Carpenter J, Adrykowski M, Cordova M et al (1998) Hot flashes in postmenopausal women treated for breast carcinoma. Cancer 82:1682-1691
8. Carpenter J, Andrykowski M (1999) Menopausal symptoms in breast cancer survivors. Oncol Nurs Forum 26:1311-1317
9. Carpenter JS, Johnson D, Wagner L, Andrykowski M (2002) Hot flashes and related outcomes in breast cancer survivors and matched comparison women. Oncol Nurs Forum 29:E16-E25
10. Colditz GA, Hankinson SE, Hunter DJ, Willett WC, Manson JE, Stampfer MJ, Hennekens C, Rosner B, Speizer FE (1995) The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med 332:1589-1593
11. Collaborative Group on Hormonal Factors in Breast Cancer (1997) Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Lancet 350:1047-1059
12. Consensus Statement (1998) Treatment of estrogen deficiency symptoms in women surviving breast cancer. The Hormone Foundation, Canadian Breast Cancer Research Initiative, National Cancer Institute of Canada, Endocrine Society, and the University of Virginia Cancer Center and Woman's Place. J Clin Endocrinol Metab 83:1993-2000 (Review)
13. Crowder KM, Gunther JM, Jones TA, Hale BD, Zhang HZ, Peterson MR et al (1999) Abnormal neurotransmission in mice lacking synaptic vesicle protein 2A (SV2A). Proc Natl Acad Sci USA 96:15268-15273
14. Daly E, Gray A, Barlow D, McPherson K, Roche M, Vessey M (1993) Measuring the impact of menopausal symptoms on quality of life. BMJ 307:836-840
15. Dew J, Eden J, Beller E et al (1998) A cohort study of hormone replacement therapy given to women previously treated for breast cancer. Climacteric 1:137-142
16. Erlik Y, Tataryn IV, Meldrum DR et al (1981) Association of waking episodes with menopausal hot flushes. JAMA 245:1741-1744
17. Evans ML, Pritts E, Vittinghoff E, McClish K, Morgan KS, Jaffe RB (2005) Management of postmenopausal hot flushes with venlafaxine hydrochloride: a randomized, controlled trial. Obstet Gynecol 105:161-166
18. Feldman BM, Voda A, Gronseth E (1985) The prevalence of hot flash and associated variables among perimenopausal women. Res Nurs Health 8(3):261-268 (Sept)
19. Finck G, Barton DL, Loprinzi CL et al (1998) Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage 16:327-333
20. Fuks B, Gillard M, Michel P, Lynch B, Vertongen P, Leprince P et al (2003) Localization and photoaffinity labeling of the levetiracetam binding site in rat brain and certain cell lines. Eur J Pharmacol 478:11-19
21. Gee NS, Brown JP, Dissanayake VU, Offord J, Thurlow R, Woodruff GN (1996) The novel anticonvulsant drug, gabapentin (Neurontin), binds to the alpha2delta subunit of a calcium channel. J Biol Chem 271:5768-5776
22. Goldberg RM, Loprinzi DL, O'Fallon JR et al (1994) Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. J Clin Oncol 12:155-158
23. Greendale G, Lee N, Arriola E (1999) The menopause. Lancet 353:571-580
24. Greendale GA, Reboussin BA, Hogan P et al (1998) Symptom relief and side effects of postmenopausal hormones: results from the postmenopausal estrogen/progestin interventions trial. Obst Gynecol 92:982-988
25. Guay DR (2003) Oxcarbazepine, topiramate, zonisamide, and levetiracetam: potential use in neuropathic pain. Am J Geriatr Pharmacother 1:18-37 (Review)
26. Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K (2003) Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol 101:337-345
27. Hoda D, Perez DG, Loprinzi CL (2003) Hot flashes in breast cancer survivors. Breast J 9:431-438 (Review)
28. Koster A (1990) Hormone replacement therapy: use patterns in 51-year-old Danish women. Maturitas 12:345-356
29. Lacey JV Jr, Mink PJ, Lubin JH et al (2002) Menopausal hormone replacement therapy and risk of ovarian cancer. JAMA 288:334-341
30. Leach JP (2004) Levetiracetam in the management of epilepsy. Hosp Med 65:740-744 (Review)
31. Loprinzi CL, Barton DL, Sloan JA et al (2002) Pilot evaluation of gabapentin for treating hot flashes. Mayo Clin Proc 77:1159-1163
32. Loprinzi CL, Barton DL, Sloan JA (2006) Whose opinion counts? J Clin Oncol 24(33):5183-5185
33. Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA et al (2007) Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone. J Clin Oncol 25:308-312
34. Loprinzi CL, Kugler JW, Sloan JA, Mailliard JA, LaVasseur BI, Barton DL, Novotny PJ, Dakhil SR, Rodger K, Rummans TA, Christensen BJ (2000) Randomized phase III controlled trial of venlafaxine in the management of hot flashes. Lancet 356:2059-2063
35. Loprinzi CL, Michalak JC, Quella SK et al (1994) Megesterol acetate for the prevention of hot flashes. N Engl J Med 331:347-352
36. Loprinzi CL, Pisansky TM, Fonseca R et al (1998) Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors. J Clin Oncol 16:2377-2381
37. Loprinzi CL, Sloan JA, Perez EA, Quella SK, Stella PJ, Mailliard JA, Halyard MY, Pruthi S, Novotny PJ, Rumman TA (2002) Phase III evaluation of fluoxetine for treatment of hot flashes. J Clin Oncol 20(6):1578-1583
38. Loprinzi CL, Zahasky KM, Sloan JA, Novotny PJ, Quella SK (2000) Tamoxifen-induced hot flashes. Clin Breast Cancer 1:52-56
39. Lukyanetz EA, Shkryl VM, Kostyuk PG (2002) Selective blockade of N-type calcium channels by levetiracetam. Epilepsia 43:9-18
40. Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh SM, Matagne A et al (2004) The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci USA 101:9861-9866
41. MacGregor CA, Canney PA, Patterson G, McDonald R, Paul J (2005) A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer. Eur J Cancer 41:708-714
42. Majumdar SR, Almasi EA, Stafford RS (2004) Promotion and prescribing of hormone therapy after report of harm by the Women's Health Initiative. JAMA 292:1983-1988
43. Margineanu DG, Klitgaard H (2000) Inhibition of neuronal hypersynchrony in vitro differentiates levetiracetam from classical antiepileptic drugs. Pharmacol Res 42:281-285
44. Margineanu DG, Klitgaard H (2003) Levetiracetam has no significant gamma-aminobutyric acid-related effect on paired-pulse interaction in the dentate gyrus of rats. Eur J Pharmacol 466:255-261
45. McKinlay SM, Jefferys M (1974) The menopausal syndrome. Br J Prev Soc Med 28:108-115
46. Moorhead T, Hannaford P, Warskyj M (1997) Prevalence and characteristics associated with use of hormone replacement therapy in Britain. Br J Obstet Gynaecol 104(3):290-297
47. Morgante G, Farina M, Cianci A, La Marca A, Petraglia F, De Leo V (2004) Veralipride administered in combination with raloxifene decreases hot flushes and improves bone density in early postmenopausal women. Gynecol Endocrinol 18:194-198
48. Nand SL, Webster MA, Baber R et al (1998) Menopausal symptom control and side-effects on continuous estrone sulfate and three doses of medroxyprogesterone acetate. Climacteric 1:211-218
49. 2+ current in pyramidal neurones of rat hippocampal slices. Neurosci Lett 306:5-8
50. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP (1982) Toxicity and response criteria of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655
51. Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ (2005) Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet 366:818-824
52. Pansini F, Albertazzi P, Bonaccorsi G et al (1994) The menopausal transition: a dynamic approach to the pathogenesis of neurovegetative complaints. Eur J Obstet Gynecol Reprod Biol 57:103-109
53. Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, Lavasseur BI, Rao RM, Fitch TR, Rowland KM, Novotny PJ, Flynn PJ, Richelson E, Fauq AH (2006) Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol 24:2836-2841
54. Pockaj BA, Loprinzi CL, Sloan JA, Novotny PJ, Barton DL, Hagenmaier A, Zhang H, Lambert GH, Reeser KA, Wisbey JA (2004) Pilot evaluation of black cohosh for the treatment of hot flashes in women. Cancer Investig 22:515-521
55. Porch JV, Lee IM, Cook NR, Rexrode KM, Burin JE (2002) Estrogen-progestin replacement therapy and breast cancer risk: the Women's Health Study (United States). Cancer Causes Control 13:847-854
56. UCB Pharma (2005) Product information: KEPPRA(R) oral solution, oral tablets, levetiracetam oral solution, oral tablets. UCB Pharma, Smyrna, GA
57. Quella SK, Loprinzi CL, Barton DL et al (2000) Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: an NCCTG trial. J Clin Oncol 18:1068-1074
58. Rigo JM, Hans G, Nguyen L, Rocher V, Belachew S, Malgrange B et al (2002) The anti-epileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA and glycine-gated currents. Br J Pharmacol 136:659-672
59. Roberts J, Chambers LF, Blake J et al (1992) Psychosocial adjustment in post-menopausal women. Can J Nurs Res 24:29-464
60. Ross RK, Paganini-Hill A, Wan PC, Pike MC (2000) Effect of hormone replacement therapy on breast cancer risk: estrogen versus estrogen plus progestin. J Natl Cancer Inst 92:328-332
61. Rossouw JE, Anderson GL, Prentice RL et al (2002) Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 288:321-333
62. Sasa M (2006) A new frontier in epilepsy: novel antiepileptogenic drugs. J Pharmacol Sci 100:487-494 (Review)
63. Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL (2002) Pathophysiology and treatment of hot flashes. Mayo Clin Proc 77:1207-1218 (Review)
64. Sievert LL, Freedman RR, Garcia JZ et al (2002) Measurement of hot flashes by sternal skin conductance and subjective hot flash report in Puebla, Mexico. Menopause 9:367-376
65. Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H (2001) Methodologic lessons learned from hot flash studies. J Clin Oncol 19:4280-4290
66. Stearns V, Beebe KL, Iyengar M, Dube E (2003) Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial. JAMA 289:2827-2834
67. Stearns V, Isaacs C, Crawford J et al (1997) A pilot trial assessing the efficacy of paroxetine hydrochloride in controlling hot flashes. Breast Cancer Res Treat 46:23-113
68. Stearns V, Slack R, Greep N, Henry-Tilman R, Osborne M, Bunnell C, Ullmer L, Gallagher A, Cullen J, Gehan E, Hayes DF, Isaacs C (2005) Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. J Clin Oncol 23:6919-6930
69. Stein KD, Jacobsen PB, Hann DM, Greenberg H, Lyman G (2000) Impact of hot flashes on quality of life among postmenopausal women being treated for breast cancer. J Pain Symptom Manage 19:436-445
70. Steinberg KK, Thacker SB, Smith SJ, Stroup DF, Zack MM, Flanders WD et al (1991) A meta-analysis of the effect of estrogen replacement therapy on the risk of breast cancer. JAMA 265:1985-1990
71. Suvanto-Luukkonen E, Koivunen R, Sundstrom H, Bloigu R, Karjalainen E, Haiva-Mallinen L, Tapanainen JS (2005) Citalopram and fluoxetine in the treatment of postmenopausal symptoms: a prospective, randomized, 9-month, placebo-controlled, double-blind study. Menopause 12:18-26
72. Tice JA, Ettinger B, Ensrud K, Wallace R, Blackwell T, Cummings SR (2003) Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. JAMA 290:207-214