Effect of a Dietary Supplement with Antioxidant and Anti-inflammatory Properties on the Intestinal Microbiota in Patients with Colon Cancer. Randomized, Placebo-controlled Clinical Trial. TERATROPHO Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in the alpha diversity index (Shannon)
研究概览
简要总结
Effect of a dietary supplement with antioxidant and anti-inflamatory properties on the intestinal microbiota in patients with colon cancer. Ramdonized placebo controlled clinical trial. Teratrophic study
详细描述
Introduction
The alteration in the microbiota plays a fundamental role in the promotion and progression of colon cancer due to various pathways such as inflammation and oxidative stress. The use of substances with anti-inflammatory and antioxidant effect could be useful for the treatment of this disease.
Methodology:
Prospective randomized clinical trial, with three parallel groups and double blind. Patients with stage II or III colon neoplasia who are going to receive post-surgical chemotherapy will be included. Patients will be randomized to one of the following groups: group 1 (25 patients): product with hydroxytyrosol extract; group 2 (25 patients): product with curcumin and selenium extract. Group 3 (25 patients): placebo. Before starting chemotherapy, stool and blood samples will be taken, and gastrointestinal symptoms, quality of life, symptoms of anxiety-depression and evaluation of nutritional status will be assessed. When starting chemotherapy, they will start with a daily intake of the assigned dietary supplement. At 3 months ± 2 weeks after starting chemotherapy (at least 2 weeks must have passed since the last chemotherapy of the fourth cycle), the same assessment will be made as in the initial visit, in addition to recording adherence to the intervention dietary supplement and new health problems that have appeared since the previous visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosis of stage II or III colo neoplasia
- •Indication of adjuvant chemotherapy according to the Protocols for the diagnosis and treatment of cancer of the Intercenter Clinical Management Unit
- •Sign the informed consent
排除标准
- •Systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, progressive systemic sclerosis -scleroderma-, idiopathic inflammatory myopathies -myositis-, vasculitis, Behçet's disease, relapsing polychondritis, etc.)
- •Mellitus diabetes type 1
- •Previous gastrointestinal resections, except for appendectomy or surgery required to treat colon neoplasia
- •Chronic intestinal pathologies (inflammatory bowel disease, celiac disease, lymphangiectasias)
- •Continued consumption of probiotics, with the exception of dairy products or other natural fermented foods
- •Chronic and continued use of NSAIDs or corticosteroids
- •Allergy to any component of the product under investigation
- •Pregnancy
- •Mean consumption of > 3 UBE of alcohol per day
- •Previous or concomitant neoplasia, unless curative treatment was received and ≥5 years have passed free of disease
- •ECOG scale greater than or equal to 3 at the start of the clinical trial
- •Grade 3-4 neuropathy that limits the use of oxaliplatin.
- •History of familial adenomatous polyposis mediated by the APC gene or by Lynch syndrome (mutations MLH1, MSH2, PMS2, MSH6).
- •Patients with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which causes poor metabolism and the use of fluoropyrimidines is contraindicated.
研究组 & 干预措施
Group 1 (25 patients)
A product of the company DCOOP, with hydroxytyrosol extract
干预措施: Experimental Treatment, DCOOP Product, Hydroxytyrosol extract (Dietary Supplement)
Group 2 (25 patients)
A product of the company Indukern, with extract of curcumin and selenium
干预措施: Experimental Treatment,Indukern product, Curcumin and selenium extract (Dietary Supplement)
Group 3 (25 patients)
Placebo
干预措施: Control Treatment (Other)
结局指标
主要结局
Change in the alpha diversity index (Shannon)
时间窗: From baseline to 3 months about 2 weeks after starting chemotherapy
This diversity index is a quantitative indicator of the number of different bacteria that are present in a stool sample, taking into account the uniformity in the distribution of these bacteria in these species. Diversity index value increases both when the number of species increases and when evenness increases. The Shannon index is a well-known diversity index used in microecological studies. The higher the Shannon index value, the higher the community diversity. It is calculated as: H = -Σpi \* ln(pi), where "H" is the Shannon Diversity Index. "Σ" is a Greek symbol that means "sum". "ln" is natural log. "pi" is the proportion of the entire community made up of species i. The minimum value the Shannon diversity index can take is 0. Such a number would tell us that there is no diversity - only one species is found in that habitat. There is no upper limit to the index.
次要结局
- Degree in "ECOG Performance Status Scale"(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in height(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Mediterranean diet adherence questionnaire(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Mean dominant arm circumference(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Chlorine in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Calcium in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- HDL cholesterol in the blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- GGT in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- ALT in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Ferritin in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Prealbumin in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in weight(From baseline to 3 months about 2 weeks after starting chemotherapy)
- BMI (body mass index) changes(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Maximum and mean value of 3 measurements in dominant hand dynamometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Calf circumference in the dominant leg(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Transverse perimeter of the quadriceps rectus muscle in the dominant thigh(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Extracellular water in bioimpedanciometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Cross-sectional area of the rectus femoris quadriceps in the dominant thigh(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Fat mass in bioimpedanciometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Lean mass in bioimpedanciometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Phase angle 50 kHz in bioimpedance measurement(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Percentage of weight lost in the last 12 months(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Mean corpuscular volume in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Creatinine in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Total cell mass in bioimpedance measurement(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Percentage of weight lost in the last 6 months(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Glucose in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Phosphorus in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Magnesium in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Appendicular muscle mass in bioimpedanciometry(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Hemoglobin in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Potassium in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Iron in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Blood cholesterol(From baseline to 3 months about 2 weeks after starting chemotherapy)
- LDL cholesterol in the blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Bilirubin in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Albumin in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- 25OH vitamin D in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Normalized prothrombin time(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Assess the effect of supplementation on quality of life: "EORTC QLQ-CR29" test.(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Leukocytes in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Lymphocytes in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Platelets in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Sodium in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Total protein in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Blood triglycerides(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Alkaline phosphatase in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Assess the effect of supplementation on quality of life: "EORTC QLQ-30" test.(From baseline to 3 months about 2 weeks after starting chemotherapy)
- C-reactive protein in blood(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Assess the effect of supplementation on symptoms of depression-anxiety(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Assess gastrointestinal tolerance to supplementation and chemotherapy(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in serum C-reactive protein(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in serum Il-6(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in serum TNF-alpha(From baseline to 3 months about 2 weeks after starting chemotherapy)
- Change in stool calprotectin(From baseline to 3 months about 2 weeks after starting chemotherapy)