Undefined
Conditions
Keywords
Colorectal Cancer Metastatic, modified Mediterranean diet, Intestinal microbiota
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.
Detailed description
The study will be divided into: * Screening visit (V0) and Baseline visit (V1): during a control visit, the patient will be asked to participate in the study. After signing the written informed consent for participation in the MIC-1 study, the patient will be screened for his nutritional status. During the visit, a folder will be used to assess nutritional status. Routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. Furthermore, the detection of anthropometric measurements (weight, height, BMI), bioimpedance analysis, estimation of calorie-protein needs and Malnutrition Universal Screening Tool (MUST) nutritional screening is envisaged. Once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. Arm A will then be given the modified Mediterranean diet (DMM), while arm B will continue to follow its usual diet. The patient will deliver the fecal sample. Subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy. * Visit V2: this visit will be carried out approximately 45 days after the baseline visit. The patient will deliver the stool sample. * Visit V3: this visit will be carried out approximately 90 days after the baseline visit. During this visit, as per clinical practice, the radiological re-evaluation will be carried out.
Interventions
OTHERNutrition
The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.
Additional biological samples will also be collected.
Sponsors
University of Milano Bicocca
Azienda Socio Sanitaria della Brianza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota | V2 (45 days after V1) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the percentage of patients with gastrointestinal effects | V2 (45 days after V1) | Comparison of the percentage of patients with gastrointestinal effects in Arm A versus Arm B. |
| Comparison of the percentage of patients with severe gastrointestinal effects | V2 (45 days after V1) | Comparison of the percentage of patients with severe gastrointestinal effects (G3/G4) in Arm A versus Arm B. |
| Variation of the change in the Firmicutes/Bacteroidetes ratio | Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3) | Evaluation of the change in the Firmicutes/Bacteroidetes ratio over 3 time points |
| Variation of the overall composition of the microbiome | Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3) | Evaluation of the overall composition of the microbiome over 3 time points |
| Variation of the microbiome and metabolome | Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3) | Evaluation of the microbiome and metabolome over 3 time points |
Countries
Italy
Contacts
Primary ContactSalvatore Artale, MD
Outcome results
None listed