Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Herbal and Botanical

Flavonoid

Quercetin

Antioxidants

Protective Agents

Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

green tea extract

quercetin

placebo

therapeutic conventional surgery

laboratory biomarker analysis

Susanne Henning, MD

This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.

PRIMARY OBJECTIVES:

I. To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy.

II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention.

III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.

IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Quercetin and Green Tea to Enhance the Bioavailability of Green Tea Polyphenols in Men Scheduled for Prostatectomy

Means and standard deviation will be calculated and the statistical difference between treatment with GTextract + quercetin compared to GTextract + placebo will be determined using Student's t-test computed by one-way analysis of variance models.

Gene-association analyses will be conducted for COMT polymorphic variants within each intervention group using SAS Genetics, version 9.1

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Stomach Neoplasms

Esophageal Neoplasms

Stomach Cancer

Esophageal Cancer

Bone Density Conservation Agents

Micronutrients

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Vitamins

Other Dietary Supplements

Vitamin D

Cholecalciferol

Curcumin

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Vitamin D3

Calciferol

Whey Protein

Ergocalciferol

Vitamin D2

Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

1,000 - 10,000 units daily based on serum levels for the duration of the study

Vitamin D3 Drops

1.5g twice daily for the duration of the study

Coriolus Versicolor

3g once daily for the duration of the study

Trident SAP 66:33 Lemon

12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)

Probiotic Pro12

1 scoop (22g) once daily during the peri-operative period (approximately 1 month pre and post-surgery) and during any adjuvant chemotherapy and radiation treatments

Provitalix Pure Whey Protein

1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation

Theracurmin 2X

700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.

Green Tea Extract

Based on the Mediterranean diet and lower glycemic index foods

Nutrition Recommendations

150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days

Physical Activity Recommendations

Activities with the intention of actively improving the participant's mental and emotional health

Psychological Recommendations

Anna Fazekas, MA, CCRP

Mark Legacy, BSc

Andrew Seely, MD, PhD, FRCSC

Dugald Seely, ND, MSc

Ellen Conte, ND

Tim Asmis, MD, FRCPC

Rebecca Auer, MD, FRCSC, FACS

Kednapa Thavorn, PhD

Dean Fergusson, PhD

Christian Finley, MD, FRCPC

Tim Ramsay, PhD

Salmaan Kanji, BSc, PharmD

Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings.

The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.

The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II

Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care - The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial - Stage II

Measured by the number of people who are enrolled in the study compared to the total number screened.

Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.

Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.

Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.

Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.

Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.

Assessing the type and frequency of communications between research staff at The Ottawa Hospital (TOH) and the Centre for Health Innovation (CHI), as well as within TOH and the CHI through number of emails, phone calls, meetings (in-person or virtual) or any other communication method.

Measured by serum Interferon Gamma Levels

Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews

Measured by serum C-Reactive Protein Levels

Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels

The Canadian College of Naturopathic Medicine

Lotte & John Hecht Memorial Foundation

The Centre for Health Innovation

University of Ottawa

Ottawa Hospital Research Institute

Skin and Connective Tissue Diseases

Leiomyoma

Infertility

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Central Nervous System Stimulants

Anticoagulants

Neuroprotective Agents

Reproductive Control Agents

Caffeine

Citric Acid

Sodium Citrate

Epigallocatechin gallate

Clomiphene

Enclomiphene

Zuclomiphene

Citrate

Epigallocatechin

Low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop green tea if she becomes pregnant

Placebo (1650mg in 6 capsules) matched (smell, taste, color, texture) capsules taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop placebo if she becomes pregnant

Green tea extract 1650 mg/day (45% EGCG) along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.

Placebo 1650 mg/day along with ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.

Placebo

Ayman Al-Hendy, MD, PhD

Heping Zhang, PhD

Lisa Schepisi

Hugh Taylor, MD

Ana-Leonor Jay

Frank Gonzalez, MD

Hiba Siblini

Ayman Al-Hendy, MD, PHD

Laura Courtright

James H Segars, MD

David Weinberg, PhD

The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment.

The population will consist of 50 women desirous of conceiving, ages ≥18 to ≤40 years (at time of consent), and known to have class 2-6 fibroids, according to the FIGO staging system.

The objective of this study is to conduct a randomized double-blinded clinical trial to determine the effect of low caffeine green tea extract on fibroids and subsequent pregnancy in women seeking fertility treatment. The investigators hypothesize that EGCG in low caffeine green tea extract will reduce the fibroid size, improve the quality of endometrium, and increase the likelihood of pregnancy. To test this hypothesis, the investigators propose a randomized placebo-controlled clinical trial to evaluate live birth outcomes for women with unexplained infertility who have uterine fibroids. Participants will be randomized to either oral low caffeine green tea extract (1650mg/day) vs. placebo along ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles.

Endpoints

Primary Endpoint:

- Our primary endpoint is cumulative live birth rate.

Secondary Endpoints:

* The conception rate.
* The miscarriage rate.
* The change of fibroid volume, symptom severity score, and health-related quality-of-life score, from baseline to completion of treatment, and endometrial receptivity biomarkers.
* Time to pregnancy

This will be a randomized, multi-center, prospective, and double-blind clinical trial of low caffeine green tea extract versus placebo. Fifty (50) participants will be randomized via computer-generated randomization schedule to receive either:

1. low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis along with Clomiphene citrate-intrauterine insemination (CC-IUI) cycle, up to 4 cycles if no pregnancy is achieved. Participant will stop green tea if she becomes pregnant.

   or
2. matched (smell, taste, color, texture) placebo capsules taken orally on a daily basis along with CC-IUI cycle, up to 4 cycles if no pregnancy is achieved. Participant will stop placebo if she becomes pregnant.

The randomization scheme will be on a 3:1 basis in favor of green tea extract, thus 37 participants will be assigned to the first arm (green tea extract) and 13 participants to the second arm (placebo).

Clomiphene citrate will be taken for 5 days on Day 3 +/- 2 days of the participant's cycle.

Two-arm parallel assignment (with 3:1 ratio)

FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea

Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea (FRIEND)

Once results are published study data will be uploaded to NICHD DASH (Data and Specimen Hub).

The number of women achieving live birth.

The number of women who have a miscarriage after conception.

The absolute change in fibroid volume (cm\^3) from baseline to completion of treatment.

The absolute change in fibroid symptom severity summary scores from baseline to completion of treatment. It consists of an 8-item symptom severity scale. All items are scored on a 5-point Likert scale, ranging from "not at all" (1) to "a very great deal" (5). A high score means a worse outcome.

The absolute change in health-related quality-of-life questionnaire summary scores from baseline to completion of treatment. It consists 29 Health-Related Quality of Life items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "none of the time" (1) to "all of the time" (5). A higher score means a worse outcome.

The time from randomization to the first date of conception found

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Chicago

University of Illinois at Chicago

Johns Hopkins University

Yale University

Susan Dwight Bliss Professor of Biostatistics and Director of Yale Collaborative Center for Statistics in Science

Infections

Condylomata Acuminata

Warts

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Polyphenon E Ointment 10%, Polyphenon E Ointment 15%

Karl R. Beutner, M.D., Ph.D.

The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.

Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo

Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

A Randomized, Double-Blind, Three-Arm Parallel-Group, Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts

MediGene

Androgens

Patients receive oral green tea extract six times daily for 4 months. Patients with a 50% decline in PSA, complete or partial response, or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 4 months receive no further treatment. Patients are followed every 3 months for 5 years or until disease progression. If disease progression, patients are followed every 6 months for 5 years.

Aminah Jatoi, MD

RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers.

PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the effectiveness and toxicity of green tea extract in patients with androgen-independent metastatic prostate cancer. II. Determine the response rate and response duration in patients treated with this regimen. III. Determine whether a decline in prostate-specific antigen (PSA) coincides with evidence of disease regression in these patients.

OUTLINE: Patients receive oral green tea extract six times daily for 4 months. Patients with a 50% decline in PSA, complete or partial response, or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 4 months receive no further treatment. Patients are followed every 3 months for 5 years or until disease progression. If disease progression, patients are followed every 6 months for 5 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery	NCT01912820	Adenocarcinoma ... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	green tea extra... quercetin placebo therapeutic con... laboratory biom...	40 Years - 75 Years	Jonsson Comprehensive Cancer Center
The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II	NCT04871412	Lung Cancer Gastric Cancer Esophageal Canc...	Vitamin D3 Drop... Coriolus Versic... Trident SAP 66:... Probiotic Pro12 Provitalix Pure... Theracurmin 2X Green Tea Extra... Nutrition Recom... Physical Activi... Psychological R...	18 Years -	Ottawa Hospital Research Institute
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery	NCT01912820	Adenocarcinoma ... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	green tea extra... quercetin placebo therapeutic con... laboratory biom...	40 Years - 75 Years	Jonsson Comprehensive Cancer Center
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea	NCT05364008	Leiomyoma, Uter...	Green Tea Extra... Placebo	18 Years - 40 Years	Yale University
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts	NCT00449982	Condylomata Acu...	Polyphenon E Oi...	18 Years -	MediGene
Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy	NCT00005828	Prostate Cancer	green tea extra...	18 Years -	Alliance for Clinical Trials in Oncology
Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy	NCT00005828	Prostate Cancer	green tea extra...	18 Years -	Alliance for Clinical Trials in Oncology
Green Tea Extract in Treating Patients With Advanced Solid Tumors	NCT00003197	Unspecified Adu...	green tea extra...	18 Years -	Memorial Sloan Kettering Cancer Center
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea	NCT05364008	Leiomyoma, Uter...	Green Tea Extra... Placebo	18 Years - 40 Years	Yale University

Spots Global Cancer Trial Database for green tea extract