Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen
NCT ID: NCT03844685
Last Updated: 2019-02-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-07-05
Study Completion Date
2016-02-23
Brief Summary
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A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen
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Detailed Description
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Premenopausal women with ER-positive breast cancer treated by surgery and receiving postoperative tamoxifen with or without LHRH analogues, who may have received pre or postoperative chemotherapy, or immunotherapy (for HER2-positive disease), are recruited to a double-blind randomized clinical trial, to receive either a dry extract of red clover (Promensil) as one tablet/day orally containing 80 mg isoflavones (treatment group), or one oral tablet/day without active principle (placebo group) for 24 months. All patients receive a diet-lifestyle intervention involving meetings with a dietician (physician) scheduled once a month for the first 6 months, and every 3 months thereafter. The dietician encourages patients to adhere to a macronutrient-balanced, low glycaemic load Mediterranean-type diet with personalized recommendations to increase intakes of unrefined cereals, pulses, vegetables, unrefined vegetable fats (e.g. olive oil, nuts, oil-containing seeds), and fish, and reduce intake of high-glycaemic-index foods and saturated animal fats. Patients are also encouraged to undertake regular physical activity. Outcomes are Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones.
The safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for endometrial thickness and breast density, and by evaluation of the effects of the serum from treated and placebo patients on ER-positive BC cell lines.
The safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for endometrial thickness and breast density, and by evaluation of the effects of the serum from treated and placebo patients on ER-positive BC cell lines.
Conditions
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Prospective, randomized, double-blind clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Patient and personnel involved in trial masked to treatment vs. placebo
Study Groups
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Treatment group
1 tablet /day of MCE-11 (Promensil) taken orally for 24 months
Group Type
EXPERIMENTAL
Promensil
Intervention Type
DRUG
1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months
Placebo group
Placebo tablet (without active principle) given once a day for 24 months
Group Type
PLACEBO_COMPARATOR
Placebo Oral Tablet
Intervention Type
DRUG
Placebo tablet (80 mg) (without active principle) given once a day for 24 months
Interventions
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Promensil
1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months
Intervention Type
DRUG
Placebo Oral Tablet
Placebo tablet (80 mg) (without active principle) given once a day for 24 months
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed operable ER-positive breast cancer
* Can be ductal carcinoma in situ (DCIS)
* Absence of locoregional relapse or distant metastasis
* Normal ovarian function
* Menopause Rating Score \> or equal to 8
* Signed informed consent to participate
* Can be ductal carcinoma in situ (DCIS)
* Absence of locoregional relapse or distant metastasis
* Normal ovarian function
* Menopause Rating Score \> or equal to 8
* Signed informed consent to participate
Exclusion Criteria
* Menopause Rating Score \<8
* Menopausal at diagnosis or at surgery
* Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
* Breast cancer recurrence
* Metastatic breast cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Living distant from center and unable to attend for check-ups and meetings.
* Menopausal at diagnosis or at surgery
* Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
* Breast cancer recurrence
* Metastatic breast cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Living distant from center and unable to attend for check-ups and meetings.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Cristina Ferraris
Milan, , Italy
Site Status
Countries
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Italy
References
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Dornstauder E, Jisa E, Unterrieder I, Krenn L, Kubelka W, Jungbauer A. Estrogenic activity of two standardized red clover extracts (Menoflavon) intended for large scale use in hormone replacement therapy. J Steroid Biochem Mol Biol. 2001 Jul;78(1):67-75. doi: 10.1016/s0960-0760(01)00075-9.
Reference Type
RESULT
Piersen CE, Booth NL, Sun Y, Liang W, Burdette JE, van Breemen RB, Geller SE, Gu C, Banuvar S, Shulman LP, Bolton JL, Farnsworth NR. Chemical and biological characterization and clinical evaluation of botanical dietary supplements: a phase I red clover extract as a model. Curr Med Chem. 2004 Jun;11(11):1361-74. doi: 10.2174/0929867043365134.
Reference Type
RESULT
Imhof M, Molzer S, Imhof M. Effects of soy isoflavones on 17beta-estradiol-induced proliferation of MCF-7 breast cancer cells. Toxicol In Vitro. 2008 Sep;22(6):1452-60. doi: 10.1016/j.tiv.2008.04.018. Epub 2008 May 4.
Reference Type
RESULT
Howes J, Waring M, Huang L, Howes LG. Long-term pharmacokinetics of an extract of isoflavones from red clover (Trifolium pratense). J Altern Complement Med. 2002 Apr;8(2):135-42. doi: 10.1089/107555302317371424.
Reference Type
RESULT
Kawakita S, Marotta F, Naito Y, Gumaste U, Jain S, Tsuchiya J, Minelli E. Effect of an isoflavones-containing red clover preparation and alkaline supplementation on bone metabolism in ovariectomized rats. Clin Interv Aging. 2009;4:91-100. doi: 10.2147/cia.s4164. Epub 2009 May 14.
Reference Type
RESULT
Atkinson C, Compston JE, Day NE, Dowsett M, Bingham SA. The effects of phytoestrogen isoflavones on bone density in women: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2004 Feb;79(2):326-33. doi: 10.1093/ajcn/79.2.326.
Reference Type
RESULT
Lipovac M, Chedraui P, Gruenhut C, Gocan A, Stammler M, Imhof M. Improvement of postmenopausal depressive and anxiety symptoms after treatment with isoflavones derived from red clover extracts. Maturitas. 2010 Mar;65(3):258-61. doi: 10.1016/j.maturitas.2009.10.014. Epub 2009 Nov 30.
Reference Type
RESULT
Imhof M, Gocan A, Reithmayr F, Lipovac M, Schimitzek C, Chedraui P, Huber J. Effects of a red clover extract (MF11RCE) on endometrium and sex hormones in postmenopausal women. Maturitas. 2006 Aug 20;55(1):76-81. doi: 10.1016/j.maturitas.2006.01.006. Epub 2006 Mar 2.
Reference Type
RESULT
Hidalgo LA, Chedraui PA, Morocho N, Ross S, San Miguel G. The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study. Gynecol Endocrinol. 2005 Nov;21(5):257-64. doi: 10.1080/09513590500361192.
Reference Type
RESULT
Terzic MM, Dotlic J, Maricic S, Mihailovic T, Tosic-Race B. Influence of red clover-derived isoflavones on serum lipid profile in postmenopausal women. J Obstet Gynaecol Res. 2009 Dec;35(6):1091-5. doi: 10.1111/j.1447-0756.2009.001059.x.
Reference Type
RESULT
Chedraui P, San Miguel G, Hidalgo L, Morocho N, Ross S. Effect of Trifolium pratense-derived isoflavones on the lipid profile of postmenopausal women with increased body mass index. Gynecol Endocrinol. 2008 Nov;24(11):620-4. doi: 10.1080/09513590802288283.
Reference Type
RESULT
Mueller M, Jungbauer A. Red clover extract: a putative source for simultaneous treatment of menopausal disorders and the metabolic syndrome. Menopause. 2008 Nov-Dec;15(6):1120-31. doi: 10.1097/gme.0b013e31817062ce.
Reference Type
RESULT
Simoncini T, Fornari L, Mannella P, Caruso A, Garibaldi S, Baldacci C, Genazzani AR. Activation of nitric oxide synthesis in human endothelial cells by red clover extracts. Menopause. 2005 Jan-Feb;12(1):69-77. doi: 10.1097/00042192-200512010-00013.
Reference Type
RESULT
Teede HJ, McGrath BP, DeSilva L, Cehun M, Fassoulakis A, Nestel PJ. Isoflavones reduce arterial stiffness: a placebo-controlled study in men and postmenopausal women. Arterioscler Thromb Vasc Biol. 2003 Jun 1;23(6):1066-71. doi: 10.1161/01.ATV.0000072967.97296.4A. Epub 2003 Apr 24.
Reference Type
RESULT
Guha N, Kwan ML, Quesenberry CP Jr, Weltzien EK, Castillo AL, Caan BJ. Soy isoflavones and risk of cancer recurrence in a cohort of breast cancer survivors: the Life After Cancer Epidemiology study. Breast Cancer Res Treat. 2009 Nov;118(2):395-405. doi: 10.1007/s10549-009-0321-5. Epub 2009 Feb 17.
Reference Type
RESULT
Chlebowski RT, Schwartz AG, Wakelee H, Anderson GL, Stefanick ML, Manson JE, Rodabough RJ, Chien JW, Wactawski-Wende J, Gass M, Kotchen JM, Johnson KC, O'Sullivan MJ, Ockene JK, Chen C, Hubbell FA; Women's Health Initiative Investigators. Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10;374(9697):1243-51. doi: 10.1016/S0140-6736(09)61526-9. Epub 2009 Sep 18.
Reference Type
RESULT
Cross HS, Kallay E, Lechner D, Gerdenitsch W, Adlercreutz H, Armbrecht HJ. Phytoestrogens and vitamin D metabolism: a new concept for the prevention and therapy of colorectal, prostate, and mammary carcinomas. J Nutr. 2004 May;134(5):1207S-1212S. doi: 10.1093/jn/134.5.1207S.
Reference Type
RESULT
Horn-Ross PL, John EM, Canchola AJ, Stewart SL, Lee MM. Phytoestrogen intake and endometrial cancer risk. J Natl Cancer Inst. 2003 Aug 6;95(15):1158-64. doi: 10.1093/jnci/djg015.
Reference Type
RESULT
Horn-Ross PL, Hoggatt KJ, Lee MM. Phytoestrogens and thyroid cancer risk: the San Francisco Bay Area thyroid cancer study. Cancer Epidemiol Biomarkers Prev. 2002 Jan;11(1):43-9.
Reference Type
RESULT
Other Identifiers
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INT 101/11
Identifier Type: -
Identifier Source: org_study_id
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