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Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer (TERATROFO)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
Experimental Treatment,Indukern product, Curcumin and selenium extract
Control Treatment
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring intestinal microbiota,, antioxidants, anti-inflammatories

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Regional Universitario de MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1 (25 patients)

Group 2 (25 patients)

Group 3 (25 patients)

Arm Description

A product of the company DCOOP, with hydroxytyrosol extract

A product of the company Indukern, with extract of curcumin and selenium

Placebo

Outcomes

Primary Outcome Measures

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 = -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.

Secondary Outcome Measures

Change in weight
Weight in kg
Change in height
Height in m
BMI (body mass index) changes
Measured by body composition analysis
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.
Maximum and mean value of 3 measurements in dominant hand dynamometry
Measured in kg
Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry
Measured in kg
Mean dominant arm circumference
Measured in cm
Calf circumference in the dominant leg
Measured in cm
Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh
Measured in cm
Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh
Measured in cm
Cross-sectional area of the rectus femoris quadriceps in the dominant thigh
Measured in in cm²
Transverse perimeter of the quadriceps rectus muscle in the dominant thigh
Measured in cm
Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue
Measured in cm
Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue
Measured in cm
Fat mass in bioimpedanciometry
Measured in kg
Lean mass in bioimpedanciometry
Measured in kg
Extracellular water in bioimpedanciometry
Measured in kg
Phase angle 50 kHz in bioimpedance measurement
Measured in º
Total cell mass in bioimpedance measurement
Measured in kg
Appendicular muscle mass in bioimpedanciometry
Measured in kg
Percentage of weight lost in the last 6 months
Measured in %.
Percentage of weight lost in the last 12 months
Measured in %.
Hemoglobin in blood
Measured in g/dl
Mean corpuscular volume in blood
Measured in in fL
Leukocytes in blood
Measured in in x10^9/l
Lymphocytes in blood
Measured in in x10^9/l
Platelets in blood
Measured in in x10^9/l
Creatinine in blood
Measured in in g/dl
Glucose in blood
Measured in in mg/dl
Sodium in blood
Measured in mEq/l
Potassium in blood
Measured in mEq/l
Chlorine in blood
Measured in mEq/l
Calcium in blood
Measured in in mg/dl
Phosphorus in blood
Measured in in mg/dl
Magnesium in blood
Measured in in mg/dl
Iron in blood
Measured in in mcg/dl
Blood cholesterol
Measured in in mg/dl
HDL cholesterol in the blood
Measured in in mg/dl
LDL cholesterol in the blood
Measured in in mg/dl
Blood triglycerides
Measured in in mg/dl
ALT in blood
Measured in U/L
GGT in blood
Measured in U/L
Alkaline phosphatase in blood
Measured in U/L
Bilirubin in blood
Measured in mg/dl
Total protein in blood
Measured in g/dl
Albumin in blood
Measured in g/dl
Ferritin in blood
Measured in ng/ml
25OH vitamin D in blood
Measured in ng/ml
Prealbumin in blood
Measured in mg/dl
C-reactive protein in blood
Measured in mg/dl
Normalized prothrombin time
Measured in in INR
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.
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.
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.
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.
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.
Change in serum C-reactive protein
Measured in mg/l
Change in serum Il-6
Measured in pg/ml
Change in serum TNF-alpha
Measured in pg/ml
Change in stool calprotectin
Measured in mcg/g

Full Information

First Posted
May 4, 2022
Last Updated
December 16, 2022
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05472753
Brief Title
Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
intestinal microbiota,, antioxidants, anti-inflammatories

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (25 patients)
Arm Type
Experimental
Arm Description
A product of the company DCOOP, with hydroxytyrosol extract
Arm Title
Group 2 (25 patients)
Arm Type
Experimental
Arm Description
A product of the company Indukern, with extract of curcumin and selenium
Arm Title
Group 3 (25 patients)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
Intervention Description
Intervention group will receive a nutritional formula from DCOOP (Spain).
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental Treatment,Indukern product, Curcumin and selenium extract
Intervention Description
Intervention group will receive a nutritional formula from Indukern (Spain).
Intervention Type
Other
Intervention Name(s)
Control Treatment
Intervention Description
Control group will receive a placebo (product loading substance)
Primary Outcome Measure Information:
Title
Change in the alpha diversity index (Shannon)
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary Outcome Measure Information:
Title
Change in weight
Description
Weight in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Change in height
Description
Height in m
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
BMI (body mass index) changes
Description
Measured by body composition analysis
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Mediterranean diet adherence questionnaire
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Maximum and mean value of 3 measurements in dominant hand dynamometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Mean dominant arm circumference
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Calf circumference in the dominant leg
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Cross-sectional area of the rectus femoris quadriceps in the dominant thigh
Description
Measured in in cm²
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Transverse perimeter of the quadriceps rectus muscle in the dominant thigh
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue
Description
Measured in cm
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Fat mass in bioimpedanciometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Lean mass in bioimpedanciometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Extracellular water in bioimpedanciometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Phase angle 50 kHz in bioimpedance measurement
Description
Measured in º
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Total cell mass in bioimpedance measurement
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Appendicular muscle mass in bioimpedanciometry
Description
Measured in kg
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Percentage of weight lost in the last 6 months
Description
Measured in %.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Percentage of weight lost in the last 12 months
Description
Measured in %.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Hemoglobin in blood
Description
Measured in g/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Mean corpuscular volume in blood
Description
Measured in in fL
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Leukocytes in blood
Description
Measured in in x10^9/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Lymphocytes in blood
Description
Measured in in x10^9/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Platelets in blood
Description
Measured in in x10^9/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Creatinine in blood
Description
Measured in in g/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Glucose in blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Sodium in blood
Description
Measured in mEq/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Potassium in blood
Description
Measured in mEq/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Chlorine in blood
Description
Measured in mEq/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Calcium in blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Phosphorus in blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Magnesium in blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Iron in blood
Description
Measured in in mcg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Blood cholesterol
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
HDL cholesterol in the blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
LDL cholesterol in the blood
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Blood triglycerides
Description
Measured in in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
ALT in blood
Description
Measured in U/L
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
GGT in blood
Description
Measured in U/L
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Alkaline phosphatase in blood
Description
Measured in U/L
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Bilirubin in blood
Description
Measured in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Total protein in blood
Description
Measured in g/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Albumin in blood
Description
Measured in g/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Ferritin in blood
Description
Measured in ng/ml
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
25OH vitamin D in blood
Description
Measured in ng/ml
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Prealbumin in blood
Description
Measured in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
C-reactive protein in blood
Description
Measured in mg/dl
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Normalized prothrombin time
Description
Measured in in INR
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Degree in "ECOG Performance Status Scale"
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Assess the effect of supplementation on quality of life: "EORTC QLQ-30" test.
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Assess the effect of supplementation on quality of life: "EORTC QLQ-CR29" test.
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Assess the effect of supplementation on symptoms of depression-anxiety
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Assess gastrointestinal tolerance to supplementation and chemotherapy
Description
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.
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Change in serum C-reactive protein
Description
Measured in mg/l
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Change in serum Il-6
Description
Measured in pg/ml
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Change in serum TNF-alpha
Description
Measured in pg/ml
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy
Title
Change in stool calprotectin
Description
Measured in mcg/g
Time Frame
From baseline to 3 months about 2 weeks after starting chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Ruiz García,, MD, PhD.
Phone
951290343/951030117
Email
nach1991@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Olveira Fuster, MD, PhD.
Phone
951290343/951030117
Email
gabrielm.olveira.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira Fuster, MD, PhD.
Organizational Affiliation
Hospital Regional Universitario de Málaga, FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Ruiz García, MD, PhD
Phone
51290343/951030117
Email
nach1991@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira Fuster, MD,PhD
Phone
951290343/951030117
Email
gabrielm.olveira.sspa@juntadeandalucia.es

12. IPD Sharing Statement

Learn more about this trial

Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer

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