Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer

Colon Cancer Clinical Trial

— TERATROFO  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472753
• Other study ID #: TERATROFO
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Ignacio Ruiz García,, MD, PhD.
• Phone: 951290343/951030117
• Email: nach1991[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Dietary Supplement:
• Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
Intervention group will receive a nutritional formula from DCOOP (Spain).
• Experimental Treatment,Indukern product, Curcumin and selenium extract
Intervention group will receive a nutritional formula from Indukern (Spain).

Other:
• Control Treatment
Control group will receive a placebo (product loading substance)

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the alpha diversity index (Shannon)	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 = -Spi * ln(pi), where "H" is the Shannon Diversity Index. "S" 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.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in weight	Weight in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in height	Height in m	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	BMI (body mass index) changes	Measured by body composition analysis	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Mediterranean diet adherence questionnaire	to evaluate adherence to a Mediterranean diet pattern. It consists of 14 items in which different components of the Mediterranean diet are evaluated (number of pieces of fruit consumed per day, number of portions of legumes consumed per week...). Each item is scored as 0 or 1. A total score of <9 indicates poor adherence, while a score of =9 indicates good adherence.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Maximum and mean value of 3 measurements in dominant hand dynamometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Mean dominant arm circumference	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Calf circumference in the dominant leg	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Cross-sectional area of the rectus femoris quadriceps in the dominant thigh	Measured in in cm²	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Transverse perimeter of the quadriceps rectus muscle in the dominant thigh	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue	Measured in cm	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Fat mass in bioimpedanciometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Lean mass in bioimpedanciometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Extracellular water in bioimpedanciometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Phase angle 50 kHz in bioimpedance measurement	Measured in º	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Total cell mass in bioimpedance measurement	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Appendicular muscle mass in bioimpedanciometry	Measured in kg	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Percentage of weight lost in the last 6 months	Measured in %.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Percentage of weight lost in the last 12 months	Measured in %.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Hemoglobin in blood	Measured in g/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Mean corpuscular volume in blood	Measured in in fL	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Leukocytes in blood	Measured in in x10^9/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Lymphocytes in blood	Measured in in x10^9/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Platelets in blood	Measured in in x10^9/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Creatinine in blood	Measured in in g/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Glucose in blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Sodium in blood	Measured in mEq/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Potassium in blood	Measured in mEq/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Chlorine in blood	Measured in mEq/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Calcium in blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Phosphorus in blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Magnesium in blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Iron in blood	Measured in in mcg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Blood cholesterol	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	HDL cholesterol in the blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	LDL cholesterol in the blood	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Blood triglycerides	Measured in in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	ALT in blood	Measured in U/L	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	GGT in blood	Measured in U/L	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Alkaline phosphatase in blood	Measured in U/L	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Bilirubin in blood	Measured in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Total protein in blood	Measured in g/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Albumin in blood	Measured in g/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Ferritin in blood	Measured in ng/ml	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	25OH vitamin D in blood	Measured in ng/ml	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Prealbumin in blood	Measured in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	C-reactive protein in blood	Measured in mg/dl	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Normalized prothrombin time	Measured in in INR	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Degree in "ECOG Performance Status Scale"	This scale was developed by the Eastern Cooperative Oncology Group (ECOG), currently the ECOG-ACRIN Cancer Research Group. It was published in 1982. The scale describes the level of functioning of a patient in terms of her ability to take care of herself, perform daily physical activity and physical capacity (walk, work…). It was devised to use standard criteria between different centers to measure how the disease affects a patient's daily living abilities. The scale has a score from 0 to 5 in whole numbers. Lower score indicates better functional capacity. Score 0 refers to fully active patients, capable of carrying out all activities as before the onset of the disease. A score of 5 indicates the death of the patient.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Assess the effect of supplementation on quality of life: "EORTC QLQ-30" test.	The "EORTC quality of life questionnaire (QLQ)" is an integrated system to assess the quality of life of cancer patients participating in international clinical trials. The main questionnaire is the "QLQ-C30". Version 3.0 is currently the standard version. The QLQ-C30 is made up of multiple-item and single-item scales. Five functionality scales, three symptom scales, a global health status/quality of life scale, and six individual items are included. Each of the multiple item scales includes a different set of items; no item appears on more than one scale. All single-item scales and measures range in score from 0 to 100. A high scale score represents a higher level of response. Thus, a high score for a functionality scale represents a high/healthy level of functionality, a high score for global health status/quality of life represents a high quality of life, but a high score for a scale or isolated items of symptoms represents a high level of symptoms/problems.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Assess the effect of supplementation on quality of life: "EORTC QLQ-CR29" test.	It is a supplemental questionnaire module to be used together with the QLQ-C30. The QLQ-CR29 incorporates 4 multi-item and 19 single-item scales. A variety of common symptoms and problems are assessed in colorectal cancer patients. The scoring approach is identical in principle to that of the scales or isolated items of functionality and symptoms of the QLQ-C30. All scales and single-item measures have a score range of 0 to 100. A high score on the functionality scale and the isolated items of functionality represents a high level of functionality, while a high score for the scales and isolated items represents a high level of functionality. of symptoms represents a high level of symptomatology or problems.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Assess the effect of supplementation on symptoms of depression-anxiety	Hospital Anxiety and Depression Scale (HADS). Its objective is to detect depressive and anxious disorders in non-psychiatric hospital services, avoiding overlapping with symptoms due to physical illness, without taking into account the physical aspects that may accompany anxiety/depression, focusing only on emotional ones. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, patients can be classified as normal (<7), doubtful (between 8 and 10) and potential clinical case (=11). The score is referred to the last week.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Assess gastrointestinal tolerance to supplementation and chemotherapy	Gastrointestinal symptoms questionnaire: an own questionnaire created for this study will be carried out in which the presence of nausea, vomiting, diarrhoea, constipation, acid reflux, early satiety, abdominal distension and abdominal pain will be evaluated. Each variable is evaluated on a scale with 4 possible responses: absent, mild, moderate, severe.	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in serum C-reactive protein	Measured in mg/l	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in serum Il-6	Measured in pg/ml	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in serum TNF-alpha	Measured in pg/ml	From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary	Change in stool calprotectin	Measured in mcg/g	From baseline to 3 months about 2 weeks after starting chemotherapy