A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North central cancer treatment group N08C7

Menopause

Volumn 19, Issue 1, 2012, Pages 48-53

  Pruthi, Sandhya ^a   Qin, Rui ^a   Terstreip, Shelby A ^b   Liu, Heshan ^a   Loprinzi, Charles L ^a   Shah, Tushar R C ^c   Tucker, Kenneth F ^c   Dakhil, Shaker R ^d   Bury, Martin J ^e   Carolla, Robert L ^f   Steen, Preston D ^b   Vuky, Jacqueline ^g   Barton, Debra L ^a  

^a MAYO CLINIC ROCHESTER   (United States)

^b MeritCare Hospital   (United States)

^c Michigan Cancer Research Consortium   (United States)

^d WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

^e GRAND RAPIDS CLINICAL ONCOLOGY PROGRAM   (United States)

^f Cancer Research for the Ozarks   (United States)

^g Virginia Mason Community Clinical Oncology Program   (United States)

Author keywords

Clinical trial; Dietary supplement; Flaxseed; Hot flashes; Menopause

Indexed keywords

ANTIDEPRESSANT AGENT; ANTIESTROGEN; AROMATASE INHIBITOR; LIGNAN; PLACEBO; SEROTONIN UPTAKE INHIBITOR; TAMOXIFEN;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; ADVERSE OUTCOME; AGED; ARTICLE; BREAST CANCER; CONTROLLED STUDY; DIARRHEA; DIET SUPPLEMENTATION; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; FEMALE; FLATULENCE; GASTROINTESTINAL SYMPTOM; HOT FLUSH; HUMAN; LINSEED; MAJOR CLINICAL STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; SELF REPORT; TREATMENT OUTCOME; VOMITING;

DIARRHEA; DIETARY FIBER; DOUBLE-BLIND METHOD; FEMALE; FLATULENCE; FLAX; HOT FLASHES; HUMANS; LIGNANS; MENOPAUSE; MIDDLE AGED; NAUSEA; PLACEBOS; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84655167220     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/gme.0b013e318223b021     Document Type: Article

References (33)

1. Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol 1995;13:2737-2744.
2. Gracia CR, Freeman EW. Acute consequences of the menopausal transition: the rise of common menopausal symptoms. Endocrinol Metab Clin North Am 2004;33:675-689. (Pubitemid 39388981)
3. Hunter M, Rendall M. Bio-psycho-socio-cultural perspectives on menopause. Best Pract Res Clin Obstet Gynaecol 2007;21:261-274. (Pubitemid 46478033)
4. Schneider HP. The quality of life in the post-menopausal woman. Best Pract Res Clin Obstet Gynaecol 2002;16:395-409. (Pubitemid 41132050)
5. Schneider HP, Maclennan AH, Feeny D. Assessment of health-related quality of life in menopause and aging. Climacteric 2008;11:93-107. (Pubitemid 351451111)
6. Notelovitz M, Lenihan JP, McDermott M, et al. Initial 17A-estradiol dose for treating vasomotor symptoms. Obstet Gynecol 2000;95:726-731. (Pubitemid 30210060)
7. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333. (Pubitemid 34761611)
8. Goodwin JW, Green SJ, Moinpour CM, et al. Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. J Clin Oncol 2008;26:1650-1656.
9. Loprinzi CL, Michalak JC, Quella SK, et al. Megestrol acetate for the prevention of hot flashes. N Engl J Med 1994;331:347-352. (Pubitemid 24233853)
10. Barton DL, LaVasseur BI, Sloan JA, et al. Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. J Clin Oncol 2010;28:3278-3283.
11. Loprinzi CL, Barton DL, Sloan JA, et al. Newer antidepressants for hot flashes-should their efficacy still be up for debate? Menopause 2009;16: 184-187.
12. Loprinzi CVS, Barton D. Centrally active nonhormonal hot flash therapies. Am J Med 2005;118:118S-123S. (Pubitemid 43083590)
13. Spratto GR, Woods AL. Physicians Desk Reference Nurse's Drug Handbook, 2006 Edition. Montvale NJ: Thomson Healthcare; 2006: p. 1568.
14. Goetz MP, Knox SK, Suman VJ, et al. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat 2007;101:113-121. (Pubitemid 47555336)
15. Goetz MP, Loprinzi CL. A hot flash on tamoxifen metabolism. J Natl Cancer Inst 2003;95:1734-1735. (Pubitemid 38008886)
16. Goetz MP, Rae JM, Suman VJ, et al. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol 2005;23:9312-9318.
17. Basch E, Bent S, Collins J, et al. Flax and flaxseed oil (Linum usitatissimum): a review by the Natural Standard Research Collaboration. J Soc Integr Oncol 2007;5:92-105. (Pubitemid 47555909)
18. Bergman Jungestrom M, Thompson LU, Dabrosin C. Flaxseed and its lignans inhibit estradiol-induced growth, angiogenesis, and secretion of vascular endothelial growth factor in human breast cancer xenografts in vivo. Clin Cancer Res 2007;13:1061-1067. (Pubitemid 46340386)
19. Touillaud MS, Thiebaut AC, Fournier A, et al. Dietary lignan intake and postmenopausal breast cancer risk by estrogen and progesterone receptor status. J Natl Cancer Inst 2007;99:475-486. (Pubitemid 47078736)
20. Dodin S, Lemay A, Jacques H, et al. The effects of flaxseed dietary supplement on lipid profile, bone mineral density, and symptoms in menopausal women: a randomized, double-blind, wheat germ placebocontrolled clinical trial. J Clin Endocrinol Metab 2005;90:1390-1397. (Pubitemid 40463994)
21. Lemay A, Dodin S, Kadri N, et al. Flaxseed dietary supplement versus hormone replacement therapy in hypercholesterolemic menopausal women. Obstet Gynecol 2002;100:495-504. (Pubitemid 35246136)
22. Lewis JE, Nickell LA, Thompson LU, et al. A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause. Menopause 2006;13:631-642. (Pubitemid 44079533)
23. Pruthi S, Thompson SL, Novotny PJ, et al. Pilot evaluation of flaxseed for the management of hot flashes. J Soc Integr Oncol 2007;5:106-112. (Pubitemid 47555910)
24. Sloan JA, Loprinzi CL, Novotny PJ, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol 2001;19:4280-4290. (Pubitemid 33096775)
25. Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage 2001;22:979-989. (Pubitemid 33152683)
26. Curran S, Andrykowski M, Stadts J. Short Form of the Profile of Mood States (POMS-SF): psychometric information. Psychol Assess 1995;7: 80-83.
27. Hilditch JR, Lewis J, Peter A, et al. A Menopause-Specific Quality of Life questionnaire: development and psychometric properties. Maturitas 1996;24:161-175.
28. Lewis JE, Hilditch JR, Wong CJ. Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire. Maturitas 2005;50:209-221. (Pubitemid 40269904)
29. Farrar JT, Young JP Jr, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-158. (Pubitemid 33016608)
30. Harris PF, Remington PL, Trentham-Dietz A, et al. Prevalence and treatment of menopausal symptoms among breast cancer survivors. J Pain Symptom Manage 2002;23:501-509. (Pubitemid 34627035)
31. Barton DL, Loprinzi CL, Quella SK, et al. Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. J Clin Oncol 1998; 16:495-500. (Pubitemid 28135591)
32. Quella SK, Loprinzi CL, Barton DL, et al. Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: a North Central Cancer Treatment Group Trial. J Clin Oncol 2000;18: 1068-1074. (Pubitemid 30123785)
33. Pockaj BA, Gallagher JG, Loprinzi CL, et al. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol 2006; 24:2836-2841. (Pubitemid 46630583)