Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment

NCT06794931 | Recruiting

• 1 other identifier: MIC-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a Western or standard diet. Specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet. The study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.

Conditions

Undefined

Keywords

Colorectal Cancer Metastatic; modified Mediterranean diet; Intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota

  Comparison of the Firmicutes/Bacteroidetes ratio after 45 days (V2) of first-line chemotherapy +/- biological agent (anti-Epidermal Growth Factor Receptor (EGFR), anti-VEGF) in patients on a modified Mediterranean diet (DMM) compared to patients on a standard Western diet (DSO)

  V2 (45 days after V1)

Secondary Outcomes (5)

• Comparison of the percentage of patients with gastrointestinal effects

  V2 (45 days after V1)

• Comparison of the percentage of patients with severe gastrointestinal effects

  V2 (45 days after V1)

• Variation of the change in the Firmicutes/Bacteroidetes ratio

  Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)

• Variation of the overall composition of the microbiome

  Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)

• Variation of the microbiome and metabolome

  Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)

Study Arms (2)

modified Mediterranean diet (DMM)

EXPERIMENTAL

It consists of a food plan in favor of bacterial biodiversity which focuses above all on foods containing high quality prebiotic fibres, instead reducing the total quantity of fibers compared to the indications provided by the Reference Intake Levels of Nutrients and Energy (LARN) for the Italian population, in consideration of the gastrointestinal side effects of chemotherapy.

Other: Nutrition; Other: Biological samples collection

standard western diet (DSO)

OTHER

The Western Diet or standard diet represents the diet most commonly used by the population in many developed countries; it reflects participants' daily eating habits, ensuring that the control group accurately represents typical eating behavior.

Other: Biological samples collection

Interventions

Nutrition OTHER

The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.

Also known as: Specific diet

modified Mediterranean diet (DMM)

Biological samples collection OTHER

Additional biological samples will also be collected.

Also known as: Microbiota analyses

modified Mediterranean diet (DMM); standard western diet (DSO)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;
• Age ≥ 18;
• Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;
• st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
• MUST score 0/1;
• Written informed consent.

You may not qualify if:

• Previous oncological medical therapies;
• Indication for parenteral and/or enteral nutrition;
• MUST score \> 2.

Sponsors & Collaborators

• Azienda Socio Sanitaria della Brianza: lead
• University of Milano Bicocca: collaborator

Study Sites (1)

U.O. di Oncologia di Vimercate, ASST-Brianza

Vimercate, MB, 20871, Italy

RECRUITING

Related Publications (1)

• Artale S, Filiali F, Beretta E, Arosio F, Cazzaniga F, Tersalvi C, Sofia M, Tagliabue P, Pozzi P, Colombo A, Carbone C, Pietrogiovanna L, Verga M, Nova P, Calori R, Renso R, Rota S, Aglione S, Manfrida I, Facendola G, Trojani A, Dazzani MC, Basciani S, Valsecchi MG, Capitoli G, Cocola C, Consolandi C. The Effects of a Modified Mediterranean Diet on Gut Microbiota and Chemotherapy Side Effects in Patients With Metastatic Colorectal Cancer Undergoing First-Line Chemotherapy With or Without Either Antiepidermal Growth Factor Receptor or Antivascular Endothelial Growth Factor Agent: Protocol for a Randomized Pilot Study in Italy. JMIR Res Protoc. 2025 Nov 14;14:e72950. doi: 10.2196/72950.

  PMID: 41236788 DERIVED

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Central Study Contacts

Salvatore Artale, MD

CONTACT

+390396657115; salvatore.artale@asst-brianza.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 23, 2028
• Study Completion (Estimated): July 23, 2028
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

IT (1)