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

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Fatigue

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Vitamins

Ascorbic Acid

Vitamin C

Ginseng

200 mg/capsule of P. quinquefolius extract, i.e. 30 mg of ginsenosides, associated with 30 mg of vitamin C extracted from Camu Camu berry

neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract

QISENG

PLACEBO

Carine SEGURA, MD

Alexandra LECONTE

Michel GOSY, MD

Pierre-Emmanuel BRACHET, MD

Jean-Briac PREVOST, MD

Emmanuel SEVIN, MD

Fatima MENIAI, MD

Laure KALUZINSKI, MD

Jean-Philippe WAGNER, MD

Olivier RIGAL, MD

JESSICA GROSJEAN, MD

This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries

Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer

Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer - Randomized, Placebo-controlled, Double-blind Study

The difference between the initial (inclusion) score and the best score based on EORTC QLQ-FA12 questionnaire (physical fatigue dimension) between assessments at 1 week (S9) and 4 weeks (S12) after the end of treatment) will be calculated

Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire

The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred

EORTC QLQ-C30 quality of life questionnaire scores

HADS anxiety and depression questionnaire scores

Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,

measured by the IPAQ questionnaire scores

measured by CAT-sleep questionnaire scores

measured by the total number of times the treatment was taken

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
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer	NCT05241405	Breast Cancer Fatigue	QISENG PLACEBO	18 Years -	Centre Francois Baclesse

Spots Global Cancer Trial Database for food supplement