Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Prostatic Neoplasms

Hot Flashes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Herbal and Botanical

Androgens

Testosterone

Soy Bean

Isoflavone

Placebos

Shehzad Basaria, M.D.

This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.

The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.

The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.

The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.

The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)

The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.

The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.

The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.

The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:

1. Correct Image: placed properly (2 points), placed poorly (1 point)
2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
3. Absent or not recognizable: 0 points

Scale ranges 0-36. with 36 being greatest cognitive function.

The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:

1. Correct Image: placed properly (2 points), placed poorly (1 point)
2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point
3. Absent or not recognizable: 0 points

Scale ranges 0-36, with 36 representing maximum cognition .

The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from "always" to "never" is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.

The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.

The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.

The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.

The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.

IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.

The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.

The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

Physicians Laboratories

National Cancer Institute (NCI)

Johns Hopkins University

Placebo

Total

>= 21 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Baseline characteristics were only recorded for the 33 participants who completed the study.

Johns Hopkins University Clinical Trials Program

Baseline

6 weeks

12 weeks

Cognitive Function as Assessed by the National Adult Reading Test (NART)

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained

Cognitive Function as Assessed by the F-A-S Test

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops

Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall

Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction

Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)

Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)

Mental Health as Assessed by the Short Form 36 Questionnaire

Physical Health as Assessed by the Short Form 36 Questionnaire

Fatigue as Assessed by the Short Form 36 Questionnaire

Physical Functioning as Assessed by the Short Form 36 Questionnaire

Body Pain as Assessed by the Short Form 36 Questionnaire

General Health Perceptions as Assessed by the Short Form 36 Questionnaire

Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire

Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire

Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Selenium

Antioxidants

Protective Agents

Trace Elements

6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)

6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)

6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC

Soy and Selenium

Aedin Cassidy, PhD

There is evidence to suggest that some dietary components can reduce the risk of breast cancer. In this pilot study two such components, isoflavones (compounds found in soy products) and selenium, will be given to women classed as at moderate to high risk of the disease. The aim is to determine some novel biomarkers of risk and to see the effect of supplementation on them.

The high incidence of breast cancer, its relatively long development phase and the financial burden to the NHS in relation to treatment makes it a prime target for dietary preventative strategies. Epidemiological and experimental investigations suggest several key dietary components that may reduce breast cancer, in particular isoflavones and selenium. Few dietary intervention studies have been conducted to investigate putative protective effects, but with our growing understanding of cancer biology and the application of new -omics technologies it is now possible to use early biomarkers of risk to assess the potential efficacy of intervention studies.

In this pilot project, we will employ a combination of disciplines to examine the effect of dietary intervention in a group of women defined by NICE guidelines as being at increased risk (moderate-high) of developing breast cancer, using metabolomics to assess the tractability of biomarkers in response to the dietary intervention. Such trials are urgently needed to examine the protective effects of diet in women classified at increased risk and who are still in the 'zone of reversibility'. The results of this study will be used to justify and optimise larger scale intervention trials and ultimately to develop appropriate dietary recommendations for the prevention of breast cancer.

A dietary intervention study based on a randomised double-blind parallel design will be conducted in 30 pre-menopausal women (age 35-50) at moderate to high risk of developing breast cancer. The metabolomic profiles of urine and serum samples (collected at baseline and after dietary intervention) will be assessed. Participants will be randomised into two groups; the placebo group (consuming 6g of non-supplemented chocolate per day) and the supplemented group (consuming 6g of chocolate containing both soy and selenium per day). The intervention will last for the duration of one menstrual cycle.

Soy, Selenium and Breast Cancer Risk

A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.

Quadram Institute Bioscience

Big C Local Cancer Research and Care

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

University of East Anglia

Professor Aedin Cassidy

Bone Density Conservation Agents

Dermatologic Agents

Vitamins

Calcium

Calcium, Dietary

Riboflavin

Phytoestrogens

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 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.

Age, Categorical

Ethnicity (NIH/OMB)

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.

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

Pomegranate

Tomato

Grape

Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.

Prostate cancer, phytochemical and PUFA

Wolfgang Lilleby, MD

Sigbjørn Smeland, MD, PhD.

We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues

A total of 102 patients with localized prostate cancer will be included in the study. A the time of inclusion, the participants will be randomized to three groups.

The intervention groups includes; control group, tomato group and multi-diet group. The intervention period is three week and will be completed before prostatectomy or radiation therapy.

Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E, glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin C, total lipidperoxides (d-ROM) and protein carbonyls.

Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Oslo University Hospital

Norwegian Cancer Society

The Research Council of Norway

University of Oslo

Professor

Caseins

soy (soy protein supplementation 50 grams/day)

milk protein supplementation 50 grams/day

placebo (milk protein supplementation 50 grams/day)

Milk

Moshe Shike, MD

To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Patient Population:

Pre and post menopausal women with breast cancer diagnosed by core needle biopsy scheduled to undergo breast cancer resection for an invasive carcinoma.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Study Design and Intervention Plan:

* Eligible patients will be consented at the time of visit with MSKCC breast surgeon and randomized to receive soy (soy protein supplementation 50 grams/day), or placebo (milk protein supplementation 50 grams/day) over the period until their surgery.
* The diagnostic biopsy (already available at time of appointment with MSKCC surgeon) will be analyzed by immunohistochemistry for proliferation (Ki67) and apoptosis (TUNEL). Additional immunohistochemistry will include HER2, TP53, cyclin D1, p27, BCL2, ER and PR.
* Excision of the breast carcinoma (lumpectomy or mastectomy) will proceed in standard fashion.
* The post-therapy excision specimen will be processed in a standard fashion. Pathologic features, margin status, and tumor size will be assessed by a light microscopic examination of histological sections. In addition to this routine processing, immunohistochemistry assays for proliferation (Ki67), apoptosis (TUNEL), HER2, TP53, cyclin D1, p27, BCL2, ER, and PR will be performed. For correlative biological studies pathologists will select approximately .5 cubic mm representative sections of the neoplastic tissues and normal adjacent breast tissue, which will be snap frozen for gene expression analysis using microarrays.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy	NCT00245518	Hot Flashes	Isoflavone Placebos	21 Years -	Johns Hopkins University
Soy, Selenium and Breast Cancer Risk	NCT00555386	Breast Cancer R...	Soy and Seleniu...	35 Years - 50 Years	University of East Anglia
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston
Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients	NCT00433797	Prostate Cancer	Prostate cancer...	-	University of Oslo
Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study	NCT00597532	Breast Cancer	Soy Milk	-	Memorial Sloan Kettering Cancer Center
Soy, Selenium and Breast Cancer Risk	NCT00555386	Breast Cancer R...	Soy and Seleniu...	35 Years - 50 Years	University of East Anglia
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)	NCT02624388	Lymphoma Childhood Lymph... Solid Tumor Childhood Solid... Neuroblastoma Ewing Sarcoma Hodgkin Lymphom... Non-Hodgkin Lym... Rhabdomyosarcom... Soft Tissue Sar... Medulloblastoma Germ Cell Tumor Wilms Tumor Brain Neoplasms Medulloblastoma... Neuroectodermal...	Genistein Placebo	1 Year - 21 Years	University of Virginia
The Specific Role of Isoflavones in Reducing Prostate Cancer Risk	NCT00617617	Prostate Cancer	Prevastein HC® Placebo	50 Years - 80 Years	H. Lee Moffitt Cancer Center and Research Institute
Soy Isoflavones and Breast Cancer Risk Reduction	NCT00204490	Breast Cancer	isoflavones carbohydrate	30 Years - 42 Years	The University of Texas Medical Branch, Galveston
The Malaysian Soy and Mammographic Density Study	NCT03686098	Breast Cancer Mammographic De...	Dietary soy Soy Supplement	45 Years - 65 Years	Cancer Research Malaysia

Spots Global Cancer Trial Database for soy

Every month we try and update this database with for soy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for soy

Every month we try and update this database with for soy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for soy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.