Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Pomegranate

Cola

Standard pomegranate extract formulation containing 20% punicalagin

Standard pomegranate extract formulation

Pomegranate extract formulation-1

Pomegranate extract formulation-2

Dr. Juan Carlos Espín, PhD

The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are:

* To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues.
* To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients.
* To compare different pomegranate extract formulations on the above.

Pomegranate Extract Supplementation in Colorectal Cancer Patients

Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues

Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.

Gene expression profile changes in tumoral and normal colon tissues

* Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH.
* Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration.
* Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea.

microRNA (miR) expression profile change in tumoral and normal colon tissues

Hospital Universitario Reina Sofia de Cordoba

National Research Council, Spain

Full Research Professor

Adenoma

Adenoma, Villous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

Neuroprotective Agents

Flavonoid

Other Dietary Supplements

Epigallocatechin gallate

Epigallocatechin

Catechin

Epicatechin

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years

Placebo, packed in hard gelatine capsules, bid for 3 years

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

* Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks
* 150mg EGCG two times daily (p.o.) over the course of three years.
* Colonoscopy after 3 years

Green tea extract of Camellia Sinensis

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

* Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks
* Placebo two times daily (p.o.) over the course of three years
* Colonoscopy after 3 years

Green tea extract of Camellia Sinensis followed by placebo

Julia Stingl, Prof.Dr.med

Thomas Seufferlein, Prof.Dr.med.

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Prevention of colorectal cancer is a major health care issue because of the high incidence of this cancer. So far, pharmaceutical chemoprevention has not gained widespread acceptance due to side effects of the chemopreventive agents used. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and clinical trials. However, controlled trials demonstrating the efficacy of nutraceuticals fo the prevention of colorectal cancer are largely missing.

The investigators present this randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Patients who underwent polypectomy for colonic polyps will be randomized after a one month verum run-in period to receive either 150mg EGCG two times daily or placebo over the course of three years. The beneficial safety profile of decaffeinated green tea extract, the quantifiable and known active content EGCG, and the accumulating evidence on its cancer preventive potential require in our view a validation of this compound for the "nutriprevention" of colorectal adenoma. Good accessibility and low costs might render this nutraceutical a top candidate for a wider use as food supplement in colon cancer prevention.

Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

Genetic and biochemical biomarkers for recurrence of adenoma or development of dysplasia and carcinoma (blood samples and histological in tissue samples of the colorectal lesions)

University of Ulm

KKS Netzwerk

Deutsche Krebshilfe e.V., Bonn (Germany)

Martin-Luther-Universität Halle-Wittenberg

Prof. Dr. med.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Stimulants

Anti-Infective Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Platelet Aggregation Inhibitors

Vasodilator Agents

Respiratory System Agents

Caffeine

Turmeric extract

Proanthocyanidin

Procyanidin

Curcumin

Resveratrol

Theobromine

Orange

Turmeric

Grape

Hesperidin

Olive

Eriodictyol

Patients consumed a polyphenol-rich dietary supplement (commercial lemon, orange, pomegranate, olive, grape, cocoa, curcuma and broccoli extracts), mainly rich in simple phenolics such as hydroxytyrosol and the polyphenols procyanidins, hesperidin, eriocitrin, curcumin, resveratrol, punicalagin and ellagic acid. Cocoa extract also contains the methylxanthines theobromine and caffeine.

Participating patients did not consume the supplement but provided biological samples to the trial

Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery

Polyphenol

Juan C. Espín, PhD

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

The objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients.

The patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. The metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using UPLC-ESI-QTOF-MS/MS.

Randomised, parallel-controlled dietary intervention

Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients

Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients

Quantification of dietary polyphenols and methylxanthines in normal and malignant mammary tissues from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS).

* Quantification (pmol/g) of each phenolic-derived metabolite in breast tissues.
* Quantification (pmol/g) of each methylxanthine-derived metabolite in breast tissues.

Quantification of dietary polyphenols and methylxanthines in urine and plasma from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS).

* Quantification of each phenolic-derived metabolite in urine and plasma (nmol/L).
* Quantification of each methylxanthine-derived metabolite in urine and plasma (nmol/L).

Hospital General Universitario Reina Sofía de Murcia

Research Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Docetaxel

Blueberry

This is a two-part open-label clinical trial of blueberry powder administered to patients with stage IV NSCLC in combination with docetaxel as a second line treatment. Patients will initially be enrolled in part 1 of the study, which is the feasibility/toxicity evaluation section of the study. Once the part I enrollment is completed, the patients will be enrolled in part 2 of the study.

The intervention consists of 2-3 packages (15 grams per package) of lyophilized blueberry powder, taken daily after mixing with natural yogurt, milk, water, or juice in combination with set dosage of docetaxel (35 milligrams per meter squared) administered intravenously every week for 4 cycles, 21-day cycles.

Blueberry powder

Goetz H Kloecker, MD

This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder, synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy will have a significant, positive effect in the response rate and overall survival.

This study is designed to evaluate the feasibility of using blueberry powder (rich in anthocyanidins) as an adjunct therapy with the conventional chemotherapy drug paclitaxel/docetaxel for treatment of NSCLC. The study is based on information from published studies in which blueberry anthocyanidins (bioflavonoids which give blueberries their color) have been shown to regulate a vast array of molecular targets, and on our own exciting and compelling preliminary data showing that blueberry anthocyanidins elicited potent synergistic chemo-sensitizing effects in two highly aggressive non-small cell lung cancer (NSCLC) cell lines.

Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer

Salvage Therapy With Docetaxel and Blueberry Powder in Non-Small Cell Lung Cancer

Completion of treatment plan by 10 patients. Feasibility and toxicity for the study will be evaluated in Part 1 of the study based on 10 patients completing the treatment plan (20 if 2 of the initial 10 patients develop toxicities).

Clinical response (complete, partial and sustained) rates will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines (version 1.1)

The cumulative number of toxic grade 3 or 4 events after each person is treated will be compared to the boundary outlined in the protocol. If the cumulative number of toxic events produces enough evidence to conclude that the true toxicity rate is greater then or equal to 33% (Pt0 = 0.33), then the trial will be stopped early for safety reasons.

Progression-free survival time defined as the time from enrollment until the first indication of disease progression or death due to any cause. Progression will be determined based on radiological measurements using RECIST criteria.

Overall Survival (OS) - time will be determined as the time from enrollment until death or last follow-up evaluation.

The changes in biomarker levels and their association with response assessments will be studied.

Functional Assessment of Cancer Therapy-Lung(FACT-L) questionnaire will be used to evaluate and measure quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-	NCT01360320	Colorectal Serr... Colorectal Tubu... Colorectal Vill... Colorectal Tubu...	Green tea extra... Green tea extra...	50 Years - 80 Years	Martin-Luther-Universität Halle-Wittenberg
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients	NCT03482401	Breast Cancer	Polyphenol	18 Years -	National Research Council, Spain
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-	NCT01360320	Colorectal Serr... Colorectal Tubu... Colorectal Vill... Colorectal Tubu...	Green tea extra... Green tea extra...	50 Years - 80 Years	Martin-Luther-Universität Halle-Wittenberg
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients	NCT03482401	Breast Cancer	Polyphenol	18 Years -	National Research Council, Spain
Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer	NCT01426620	Non-small Cell ...	Blueberry powde...	18 Years -	University of Louisville
Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients	NCT03482401	Breast Cancer	Polyphenol	18 Years -	National Research Council, Spain

Spots Global Cancer Trial Database for polyphenol

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

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