Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud75 enrolled

Overview

Effect of a dietary supplement with antioxidant and anti-inflamatory properties on the intestinal microbiota in patients with colon cancer. Ramdonized placebo controlled clinical trial. Teratrophic study

Introduction: The alteration in the microbiota plays a fundamental role in the promotion and progression of colon cancer due to various pathways such as inflammation and oxidative stress. The use of substances with anti-inflammatory and antioxidant effect could be useful for the treatment of this disease. Methodology: Prospective randomized clinical trial, with three parallel groups and double blind. Patients with stage II or III colon neoplasia who are going to receive post-surgical chemotherapy will be included. Patients will be randomized to one of the following groups: group 1 (25 patients): product with hydroxytyrosol extract; group 2 (25 patients): product with curcumin and selenium extract. Group 3 (25 patients): placebo. Before starting chemotherapy, stool and blood samples will be taken, and gastrointestinal symptoms, quality of life, symptoms of anxiety-depression and evaluation of nutritional status will be assessed. When starting chemotherapy, they will start with a daily intake of the assigned dietary supplement. At 3 months ± 2 weeks after starting chemotherapy (at least 2 weeks must have passed since the last chemotherapy of the fourth cycle), the same assessment will be made as in the initial visit, in addition to recording adherence to the intervention dietary supplement and new health problems that have appeared since the previous visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

Experimental Treatment, DCOOP Product, Hydroxytyrosol extractDIETARY_SUPPLEMENT

Intervention group will receive a nutritional formula from DCOOP (Spain).

Experimental Treatment,Indukern product, Curcumin and selenium extractDIETARY_SUPPLEMENT

Intervention group will receive a nutritional formula from Indukern (Spain).

Control TreatmentOTHER

Control group will receive a placebo (product loading substance)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of stage II or III colo neoplasia * Indication of adjuvant chemotherapy according to the Protocols for the diagnosis and treatment of cancer of the Intercenter Clinical Management Unit * Sign the informed consent Exclusion Criteria: * Systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, progressive systemic sclerosis -scleroderma-, idiopathic inflammatory myopathies -myositis-, vasculitis, Behçet's disease, relapsing polychondritis, etc.) * Mellitus diabetes type 1 * Previous gastrointestinal resections, except for appendectomy or surgery required to treat colon neoplasia * Chronic intestinal pathologies (inflammatory bowel disease, celiac disease, lymphangiectasias) * Continued consumption of probiotics, with the exception of dairy products or other natural fermented foods * Chronic and continued use of NSAIDs or corticosteroids * Allergy to any component of the product under investigation * Pregnancy * Mean consumption of \> 3 UBE of alcohol per day * Previous or concomitant neoplasia, unless curative treatment was received and ≥5 years have passed free of disease * ECOG scale greater than or equal to 3 at the start of the clinical trial * Grade 3-4 neuropathy that limits the use of oxaliplatin. * History of familial adenomatous polyposis mediated by the APC gene or by Lynch syndrome (mutations MLH1, MSH2, PMS2, MSH6). * Patients with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which causes poor metabolism and the use of fluoropyrimidines is contraindicated.

Locations (1)

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Outcomes

Primary Outcomes

Change in the alpha diversity index (Shannon)

This diversity index is a quantitative indicator of the number of different bacteria that are present in a stool sample, taking into account the uniformity in the distribution of these bacteria in these species. Diversity index value increases both when the number of species increases and when evenness increases. The Shannon index is a well-known diversity index used in microecological studies. The higher the Shannon index value, the higher the community diversity. It is calculated as: H = -Σpi \* ln(pi), where "H" is the Shannon Diversity Index. "Σ" is a Greek symbol that means "sum". "ln" is natural log. "pi" is the proportion of the entire community made up of species i. The minimum value the Shannon diversity index can take is 0. Such a number would tell us that there is no diversity - only one species is found in that habitat. There is no upper limit to the index.