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

ConditionUndefined
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAzienda Socio Sanitaria della Brianza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Previous oncological medical therapies;

Indication for parenteral and/or enteral nutrition;

MUST score > 2.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutrition

    Other intervention

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

  • Biological samples collection

    Other intervention

    Additional biological samples will also be collected.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: modified Mediterranean diet (DMM)Experimental treatment 2 interventions
Group B: standard western diet (DSO)Other 1 intervention

Trial outcomes

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)

Time frame
V2 (45 days after V1)

Secondary outcomes

1

Comparison of the percentage of patients with gastrointestinal effects

Comparison of the percentage of patients with gastrointestinal effects in Arm A versus Arm B.

Time frame
V2 (45 days after V1)
2

Comparison of the percentage of patients with severe gastrointestinal effects

Comparison of the percentage of patients with severe gastrointestinal effects (G3/G4) in Arm A versus Arm B.

Time frame
V2 (45 days after V1)
3

Variation of the change in the Firmicutes/Bacteroidetes ratio

Evaluation of the change in the Firmicutes/Bacteroidetes ratio over 3 time points

Time frame
Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
4

Variation of the overall composition of the microbiome

Evaluation of the overall composition of the microbiome over 3 time points

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

Other outcomes

Sponsors and contacts

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Azienda Socio Sanitaria della Brianza

Lead sponsor

University of Milano Bicocca

Collaborator

Source ClinicalTrials.gov
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