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

Recurrence

Disease Attributes

Ingested 47 mg of isoflavone in three 8 oz servings per day

Charles J. Rosser, MD

Primary Outcome Measures:

Decrease in rate of serum PSA rise

Secondary Outcome Measures:

Adherence to treatment regimens

Quality of life as assessed by FACT-P at baseline and at 12 months of treatment

Modulation of serum testosterone,isoflavone metabolites, and cholesterol

Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

* Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).
* Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.
* Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.
* Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.

Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.

University of Florida

Nervous System Diseases

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Brain Neoplasms

Neuroblastoma

Sarcoma

Lymphoma

Hodgkin Disease

Wilms Tumor

Medulloblastoma

Sarcoma, Ewing

Rhabdomyosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Connective and Soft Tissue

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Myosarcoma

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Glioma

Kidney Neoplasms

Urologic Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Genetic Diseases, Inborn

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Neuroepithelioma

Medulloblastoma, Childhood

Antineoplastic Agents

Estrogens

Genistein

Protective Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Phytoestrogens

Hormones

Hormone Antagonists

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4

Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4

Estrogen-like compound (isoflavone) derived from soybeans

William C. Petersen, Jr., M.D.

Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.

This is a multi-center, randomized, double blind, placebo-controlled crossover study to evaluate the effect of soy isoflavones on the short term untoward effects of myelosuppressive chemotherapy used to treat pediatric cancers. Newly diagnosed cancer patients aged 1-21 years will be registered to the study and informed consent will be obtained prior to any study-related procedures. Stratification will be based on length of chemotherapy cycles, between 14 day and 21 day cycles. Within strata registered subjects will be randomized 1:1 to one of two schedules:

Arm A: Subjects will receive genistein daily throughout chemotherapy cycles 1 and 2, and placebo during chemotherapy cycles 3 and 4

Arm B: Subjects will receive placebo daily throughout chemotherapy cycles 1 and 2, and genistein during chemotherapy cycles 3 and 4

Subjects will be assessed for safety and efficacy during each cycle with clinical labs, cytokine panels, and physical exams. Drug compliance will be monitored by use of a patient diary as well as monitoring of serum genistein levels. Adverse events will be monitored starting on Cycle 1 Day 1 through 30 days following the last day of protocol therapy (genistein/placebo).

Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)

A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy

This includes hearing loss/tinnitus, motor neuropathy, oral mucositis

University of Virginia

Director, Pediatric Novel Therapeutics Program (Hematology/Oncology)

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4

Genistein: Estrogen-like compound (isoflavone) derived from soybeans

Placebo: Pill that contains no medicine

Arm A: Genistein Followed by Placebo - GENISTEIN Cycles

Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4

Genistein: Estrogen-like compound (isoflavone) derived from soybeans

Placebo: Pill that contains no medicine

Arm B: Placebo Followed by Genistein - GENISTEIN Cycles

Arm A: Genistein Followed by Placebo - PLACEBO Cycles

Arm B: Placebo Followed by Genistein - PLACEBO Cycles

Arm A: Genistein Followed by Placebo

Arm B: Placebo Followed by Genistein

Age, Categorical

Age, Continuous

Race (NIH/OMB)

William Petersen

Genistein cycles

Placebo cycles

Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy

ESR, Genistein cycles

ESR, Placebo cycles

Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy

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
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer	NCT00596895	Biochemical Rec...	Isoflavone	45 Years - 80 Years	University of Florida
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer	NCT00596895	Biochemical Rec...	Isoflavone	45 Years - 80 Years	University of Florida
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

Spots Global Cancer Trial Database for isoflavone

Every month we try and update this database with for isoflavone 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 isoflavone

Every month we try and update this database with for isoflavone 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 isoflavone 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.