Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer

NCT ID: NCT05472753

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2024-05-31

Brief Summary

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

Detailed Description

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (25 patients)

A product of the company DCOOP, with hydroxytyrosol extract

Group Type: EXPERIMENTAL

Experimental Treatment, DCOOP Product, Hydroxytyrosol extract

Intervention Type: DIETARY_SUPPLEMENT

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

Group 2 (25 patients)

A product of the company Indukern, with extract of curcumin and selenium

Group Type: EXPERIMENTAL

Experimental Treatment,Indukern product, Curcumin and selenium extract

Intervention Type: DIETARY_SUPPLEMENT

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

Group 3 (25 patients)

Placebo

Group Type: PLACEBO_COMPARATOR

Control Treatment

Intervention Type: OTHER

Control group will receive a placebo (product loading substance)

Interventions

Experimental Treatment, DCOOP Product, Hydroxytyrosol extract

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

Intervention Type: DIETARY_SUPPLEMENT

Experimental Treatment,Indukern product, Curcumin and selenium extract

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

Intervention Type: DIETARY_SUPPLEMENT

Control Treatment

Control group will receive a placebo (product loading substance)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira Fuster, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga, FIMABIS

Locations

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Countries

Spain

Other Identifiers

TERATROFO

Identifier Type: -

Identifier Source: org_study_id