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

2 ounces of Acai Juice Product by mouth twice daily.

2 ounces of Acai Juice Product twice daily.

Acai Juice Product

Elaine T Lam, M.D.

Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling times do not require immediate treatment with androgen deprivation therapy and may be safely observed. In these situations where current treatment options may cause more unnecessary side effects than anticipated benefit, it is reasonable to use a low-risk natural product such as Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer effects.

In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.

Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA

A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)

PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.

Doubling time of PSA is the time that it takes for PSA to increase by 100%. Doubling time was calculated prior to starting study treatment and after starting study treatment.

University of Colorado, Denver

2 ounces of Acai Juice Product by mouth twice daily.

Acai Juice Product: 2 ounces of Acai Juice Product twice daily.

Acai Juice

Age, Continuous

Sex: Female, Male

Gleason score is a system of grading prostate cancer tissue. A pathologist examines each biopsy core and determines a Gleason sum (X+Y=Z), ranging from 6 to 10. Gleason 6 cancers appear similar to normal prostate tissue and indicate that the tumor is less likely to spread and that have a low risk of recurrence after initial treatment. Gleason 8, 9, 10 cancers are high risk cancers, indicating that the tumor is more likely to spread and there is a high risk of cancer recurrence after initial treatment. Gleason 7 cancers are considered intermediate risk.

Gleason Score

Baseline PSA

Elaine Lam, MD

PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline

Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline

Overall Study

Reishi

Shiitake

Maitake

Treatment with MICODIGEST 2.0 will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20mL/day (10mL before breakfast and 10 mL before dinner) for 4-6 weeks.

Treatment with placebo will initiate with 10mL/day (before breakfast or before lunch) for 7 days, and rise to 20 mL/day (before breakfast and before dinner) for 4-6 weeks.

MICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes

MICODIGEST 2.0 supplement

Placebo supplement

Joaquín Cubiella, MD PhD

Most of Colorectal cancer (CRC) diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used prior to the admission for the prevention of postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.

It seems the combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Therefore, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery.

Based on this hypothesis, we have designed a double-bind randomized clinical trial to evaluate the effect of MICODIGEST 2.0 on the complications after surgery with curative intent for CRC.

Colorectal cancer (CRC) is one of the most common malignancies in western countries. Most of the CRC diagnosed are candidates for surgical resection with curative intent. Cure rates after surgery vary between 92 % and 67 % depending on the tumor stage. However, colorectal surgery is associated with some complications that could be life-threatening.

Antibiotic prophylaxis is commonly used prior to the admission for the prevention of this postoperative complications. Several studies have shown that antibiotic administration reduces the risk of infections associated with surgery. Nevertheless, this intervention does not modify the mortality and severity of other complications detected. Further, antibiotic prophylaxis could change the intestinal microbiota and promote adverse inflammatory outcomes in CRC patients after surgery.

Fungal polysaccharides have attracted attention because of their role in gut microbiota modulation. It seems that this type of polysaccharides could reduce pathogen levels and stimulate the growth of beneficial microorganism. Anti-inflammatory activity has also been described for these fungal polysaccharides. It seems the combination of different fungal extracts would send multiple stimuli to the immune system increasing intracellular reactions and interactions. Thus, the fungal extract nutraceutical MICODIGEST 2.0 could be used to reduced the complications after CRC surgery. MICODIGEST 2.0 is available since 2016 without any adverse effect reported.

For all these reasons we have designed a double-bind randomized clinical trial to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.

Apart from this purpose, we have also set the following secondary objectives:

* To evaluate the safety of MICODIGEST 2.0 in CRC patients.
* To evaluate the effect of MICODIGEST 2.0 on feal microbiome composition and diversity.
* To evaluate the effect of MICODIGEST 2.0 on inflammatory pattern, dietary pattern and quality of life.
* To analyze the effect of microbiome, inflammatory and dietary pattern on complications after surgery.

CRC candidates for surgery with curative intent will be considered to include in the study. Patients who fulfill criteria will be screened and randomly allocated to be treated with MICODIGEST 2.0 or placebo previous to the admission. Patients will be also stratified based on tumor location (distal or proximal to splenic flexure).

Patients will be followed for 4-6 weeks until surgery intervention.

Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer

Double-blind Randomized Clinical Trial to Evaluate the Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery With Curative Intent for Colorectal Cancer

Anastomotic failure, infection, prolonged ileus, systemic complications and other will be measured. Clavien-Dindo classification will be used for grading the severity of these postoperative complications. These analysis will be measured to evaluate the effect of MICODEGIST 2.0 on the complications after surgery with curative intent for CRC.

Adverse effects will be considered during follow-up and after surgery using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. This analysis will be measured to evaluate the safety of MICODIGEST 2.0 in CRC patients.

High-quality DNA extraction will be performed in fecal samples. The bacterial 16S ribosomal ribonucleic acid gene will be sequencing on an Illumina MiSeq. Metagenomic species and a database with \>200.000 strains will be used to define the microbiome composition. This analysis will be used to evaluate the effect of MICODIGEST 2.0 on feal microbiome composition.

Neutrophil/Lymphocyte will be measured dividing the absolute number of neutrophils by the absolute number of lymphocytes from peripheral blood sample. This inflammatory biomarker will be used to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.

CRP levels (mg/dL) from peripheral blood samples will be measured to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.

TNF-apha (pg/mL) and IL-6 (pg/mL) from peripheral blood samples will be measured to evaluate the effect of MICODIGEST 2.0 on inflammatory pattern.

Patient-Generated Subjective Global Assessment survey (PG-SGA) will be used to assess the nutritional status. At the end of this survey, the patient will be rated nutritionally in one of three categories: "Well-nourished or anabolic" (PG-SGA - A), "Moderately or suspected of being undernourished" (PG-SGA B) and "Severely undernourished" (PG-SGA C). This analysis will be performed to evaluate the effect of MICODIGEST 2.0 on dietary pattern.

The 36-item Short Form Health Survey (SF-36) will be used to measure the health-related quality-of-life. The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. This analysis will be perfomed to evaluate the effect of MICODIGEST 2.0 on 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
Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA	NCT01521949	Prostate Cancer	Acai Juice Prod...	18 Years - 89 Years	University of Colorado, Denver
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA	NCT01521949	Prostate Cancer	Acai Juice Prod...	18 Years - 89 Years	University of Colorado, Denver
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Effect of the Nutraceutical "MICODIGEST 2.0" on the Complications After Surgery for Colorectal Cancer	NCT04821258	Colorectal Canc... Surgery--Compli...	MICODIGEST 2.0 ... Placebo supplem...	18 Years - 85 Years	Fundacin Biomedica Galicia Sur

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