Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Inflammation

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Hormones

Jenny Chang-Claude, Prof. Dr.

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview.

Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians.

The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up.

The primary objectives of this study are

* To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors.
* To examine the influence of genetic variants on breast cancer relapse and survival
* To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis.
* To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type.
* To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.

Nonfasting serum or plasma samples provided at recruitment and follow-up by the patients are stored at -80°C.

Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis

The Influence of Lifestyle and Genetic Risk Factors, Circulating Inflammatory Biomarkers and Menopausal Hormone Therapy on Long-term Prognosis After Postmenopausal Breast Cancer

Risk of mortality (all-cause, breast cancer specific)

German Cancer Research Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Anticoagulants

Reproductive Control Agents

Other Dietary Supplements

Estradiol

Citric Acid

Sodium Citrate

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Phytoestrogens

Clomiphene

Enclomiphene

Zuclomiphene

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogens

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

only50 mg orally every 8 hours started from cycle day 3 for 5 days

2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC

20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

phytoestrogen

estradiol valerate

50 mg orally every 8 hours started from cycle day 3 for 5 days

clomiphene citrate

Ahmed Maged, MD

Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome

Cairo University

Assistant professor

Micronutrients

Bone Density Conservation Agents

Dermatologic Agents

Herbal and Botanical

Vitamins

Calcium

Calcium, Dietary

Riboflavin

Soy Bean

Vitamin B2

soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.

isoflavones

carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.

carbohydrate

Lee-Jane W Lu, Ph.D.

Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.

This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.

One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler

Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol.

Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.

Soy Isoflavones and Breast Cancer Risk Reduction

Mammographic Density and Soy Isoflavones

Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.

Area of FGBT in mammogram. The timepoints were combined and summed.

Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed.

National Cancer Institute (NCI)

National Center for Research Resources (NCRR)

The University of Texas Medical Branch, Galveston

Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for up to 2 years.

Soy Isoflavones

Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for up to 2 years.

Placebo

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.

FGBT%

Dr. Lee Jane W. Lu

(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.

(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.

Baseline

Year 1

Year 2

Subjects with at least 1 treatment image.

Fibroglandular Tissue in Total Breast (FGBT%)

Three Soy Isoflavones participants had missing mammograms.

Breast Density by Mammography

Hip bone mineral density

Spine bone mineral density

Whole body bone mineral density

Intention to treat participants. Two placebo and one isoflavone subjects had breast images but no DXA tests.

Bone Mineral Density

Enrollment/Allocation of Qualified Women

Follow-up <1 Year

Follow-up >1 to <2 Years

Follow-up 2 Years

Antineoplastic Agents

Anastrozole

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Flax

Flaxseed 25 mg per day and 1 placebo pill per day

25 mg flaxseed per day and 1 mg anastrozole pill per day

flaxseed

Tracey L O'Connor, MD

The proposed study plans to examine the effect of flaxseed consumption, a phytoestrogen rich food, compared to aromatase inhibitors as a complementary approach to treating estrogen receptor positive breast cancer, as well as the effect of combined flaxseed and aromatase inhibitor therapy on breast cancer treatment. Because of the increasing use of both complementary and alternative approaches to treatment, and the use of aromatase inhibitors in the treatment of breast cancer, the proposed study has potential to provide important clinical information about the effect of foods high in phytoestrogens on a common endocrine therapy used in breast cancer.

Although the 10 year survival rate for women with early stage breast cancer is very good, distant recurrence is still a serious concern, especially for estrogen receptor positive women. Consequently, breast cancer survivors are interested in therapies that might improve their recurrence free survival (RFS). Used in postmenopausal women, aromatase inhibitors (AI) block the peripheral conversion of androgens to estrogen, effectively lowering the estradiol available to promote breast tumor proliferation. However, use of AIs is associated with hot flashes, joint pain, bone loss, and an increase in cardiac events. Furthermore, many breast tumors eventually develop resistance to hormonal treatments. Complementary and alternative medicines (CAMs) are widely used by cancer survivors in an attempt to reduce disease recurrence with fewer side effects and potential health benefits, and use is particularly prevalent among breast cancer survivors. Flaxseed (FS) is a commonly available food often consumed as a dietary supplement and is the richest food source of lignans, a phytoestrogen. In experimental models, flaxseed consumption has been shown to exhibit a number of activities that suggest a potential benefit of flaxseed in the adjuvant setting. However, the majority of human studies investigating the biologic effects of flaxseed have involved healthy women. There is a paucity of clinical data regarding the efficacy and safety of use of flaxseed among women with breast cancer, especially among those receiving AIs. Because the phytoestrogens in flaxseed can influence many of the same biologic pathways affected by hormonal agents, diet-drug interactions are possible. Additionally, it is possible flaxseed could act through growth and signaling pathways, modifying the development of endocrine resistance. Potential synergistic or antagonistic effects between flaxseed and antiestrogens are of particular interest given the increasing use of AIs to treat postmenopausal women with hormone responsive disease. We propose to conduct a pilot 2x2 factorial randomized intervention study between tumor biopsy and resection, in postmenopausal women diagnosed with ER positive breast cancer, to assess the effects of flaxseed and AI on a number of steroid hormone and tumor-related characteristics associated with long-term survival, and to investigate the potential interaction between flaxseed and AI on tumor expression of Ki-67, caspase, ERα, ERβ, PgR, HER2, IGF1, IGFIR. The pre-surgical setting offers a unique opportunity to rapidly obtain information on intervention related effects on growth factor and signaling pathways related to tumor characteristics in a short time period without the interference of other treatments. We hypothesize that both flaxseed and AI interventions will independently favorably affect growth factor and signaling pathway protein expression resulting in reduced tumor proliferation and increased apoptosis. We further hypothesize that these improvements will be reflected in improved recurrence scores as estimated by the Mammostrat antibody panel (Applied Genomics Incorporated). The proposed study will provide important clinical data for future dietary intervention studies involving phytoestrogen lignans from flaxseed.

Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics

Flaxseed vs. Aromatase Inhibitors: Breast Tumor Characteristics and Prognosis

Mean percentage of cells expressing estrogen receptor (ER-beta)

Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)

National Center for Complementary and Integrative Health (NCCIH)

AstraZeneca

Roswell Park Cancer Institute

25 mg flaxseed per day and 1 mg anastrozole pill per day

Anastrozole: 1 mg per day

flaxseed: 25 g per day ground

Arm A - Flaxseed & Active Anastrazole

Flaxseed 25 mg per day and 1 placebo pill per day

flaxseed: 25 g per day ground

Arm B - Flaxseed

Anastrozole 1 mg pill per day

Anastrozole: 1 mg per day

Arm C - Anastrozole

Placebo pill 1 per day

Placebo: Placebo pill 1 per day

Arm D - Placebo

Age, Continuous

Race (NIH/OMB)

Senior Administrator, Compliance - Clinical Research Services

Biopsy

Surgical resection

All treated and eligible patients with a large enough of a sample for analysis

Expression of Estrogen Receptor (ER-beta)

Progesterone Receptor (PR) Expression

All treated and eligible patients with a large enough of a sample for analysis.

Human Epidermal Growth Factor Receptor 2 (Her2) Expression

Growth Hormone Serum Levels IGF-1

Overall Study

Polyps

Adenomatous Polyps

Intestinal Polyps

Pathological Conditions, Anatomical

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Cola

urinary phytoestrogen excretion and intestinal microbiota evaluation

Alfredo Di Leo

INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have produced conflicting results. The literature suggests that some subclasses of phytoestrogens may have protective effects against CRC and colon adenomas, but most of these results come from population studies based on the dietary intake of phytoestrogens. On these premises, it is possible to hypothesize that the variability of the data reported in the literature may be due to the fact that the real absorption of phytoestrogens (by assessing their concentration in the serum or urine) and/or the ability of the single individual of producing equol was not evaluated.

PURPOSE: In the present study, the association between the phytoestrogens intake and the prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake but also on the measurement their intestinal absorption. Moreover, a specific evaluation of equol production by the intestinal flora was performed. Finally, intestinal bacteria involved in equol production were evaluated.

MATERIALS AND METHODS: Patients with sporadic colon adenomas were enrolled in group I (case) and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled in group II (control). All participants underwent the following evaluations: BMI, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens \[by high pressure liquid chromatography (HPLC)\] and intestinal flora \[by mass spectrometry with Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology\]. At the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs.

Phytoestrogens and Colonic Adenomatous Polyps

Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon

It will be evaluated on the basis of their 24h urine excretion

University of Bari

Researcher

Recurrence

Disease Progression

Miriam V Dwek, PhD

Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.

Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.

Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis	NCT03401034	Breast Cancer Breast Cancer M... Breast Cancer S... Postmenopausal ... Lifestyle Genetic Factors Inflammation Inflammatory Bi... Hormone Therapy Phytoestrogens		50 Years - 74 Years	German Cancer Research Center
Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS	NCT02352597	Polycystic Ovar...	phytoestrogen estradiol valer... clomiphene citr...	20 Years - 37 Years	Cairo University
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston
Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics	NCT00612560	Breast Cancer	Anastrozole flaxseed Placebo	18 Years - 85 Years	Roswell Park Cancer Institute
Phytoestrogens and Colonic Adenomatous Polyps	NCT03417258	Intestinal Poly...		50 Years - 75 Years	University of Bari
Phytoestrogens and Colonic Adenomatous Polyps	NCT03417258	Intestinal Poly...		50 Years - 75 Years	University of Bari
The Role of Diet and Lifestyle in Breast Cancer Survival	NCT00701584	Breast Cancer		18 Years - 75 Years	University College London Hospitals
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston

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