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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Previous oncological medical therapies;
- •Indication for parenteral and/or enteral nutrition;
- •MUST score > 2.
研究组 & 干预措施
modified Mediterranean diet (DMM)
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.
干预措施: Nutrition (Other)
modified Mediterranean diet (DMM)
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.
干预措施: Biological samples collection (Other)
standard western diet (DSO)
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.
干预措施: Biological samples collection (Other)
结局指标
主要结局
Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota
时间窗: 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)
次要结局
- Comparison of the percentage of patients with gastrointestinal effects(V2 (45 days after V1))
- Variation of the microbiome and metabolome(Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3))
- 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))