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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

Selenium

Antioxidants

Tomato

Grape

Soy Bean

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

pomegranate extract

pomegranate juice

placebo

Allan J Pantuck, MD

Arie S Belldegrun, MD

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.

The primary objectives are to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study. Secondary objectives are to determine the effect of the pomegranate treatment on the change in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to determine the effect of the pomegranate treatment on response rates for positive PSA doubling times and for declining post-treatment PSA levels (negative doubling times).

Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer

A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer

Roll International Corporation

Symptoms and General Pathology

Recurrence

3 POMx capsules

1 POMx capsule

Michael Carducci, MD

When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.

The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry.

Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study

Safety and Efficacy of POMx in Men With Prostate Cancer: An 18-Month, Randomized, Double-Blind, Dose-Finding Study of the Effects of Two (2) Doses of Pomegranate Juice Extract Capsules (1 or 3 Capsules/Day) on Rising Prostate Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

All subjects who have a baseline PSA value and at least 1 on study PSA value. The PSADT will be calculated as ln 2 (0.693)/ β (slope of the linear regression fit to ln PSA vs. time in months).

Incidence of adverse events Changes in vital signs

OR: Decrease of 50% or more in the PSA PD: For subjects who achieved a \>50% decline in PSA: An increase in PSA value by 50%. Changes in PSA below 5 ng/dL will not be considered assessable for progression.

For subjects whose PSA has not decreased by 50%: An increase in PSA value \>50% of baseline. The PSA must have risen by at least 5 ng/dL.

OR any radiographic or symptomatic documentation of metastatic or recurrent disease.

SD: Does not qualify as objective response or progressive disease.

POM Wonderful LLC

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
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients	NCT00433797	Prostate Cancer	Prostate cancer...	-	University of Oslo
Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer	NCT00732043	Prostate Cancer	pomegranate ext... pomegranate jui... placebo	18 Years -	Roll International Corporation
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study	NCT01220817	Recurrent Prost...	3 POMx capsules 1 POMx capsule	18 Years -	POM Wonderful LLC
Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer	NCT00732043	Prostate Cancer	pomegranate ext... pomegranate jui... placebo	18 Years -	Roll International Corporation

Spots Global Cancer Trial Database for pomegranate

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

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