Clinical trial · Interventional
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
Randomized Pilot Study on the Impact of a Modified Mediterranean Diet (DMM) on the Intestinal Microbiota and Clinical Outcome in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Undefined | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological samples collection | Other | — | UNRESOLVED |
| Nutrition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- modified Mediterranean diet (DMM)
- description
- 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.
- interventionNames
- Other: Nutrition
- Other: Biological samples collection
- type
- OTHER
- label
- standard western diet (DSO)
- description
- 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.
- interventionNames
- Other: Biological samples collection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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; * 1st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF); * MUST score 0/1; * Written informed consent. Exclusion Criteria: * Previous oncological medical therapies; * Indication for parenteral and/or enteral nutrition; * MUST score \> 2.
References
Publications (1)
- DERIVEDArtale 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