Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472753
Other study ID # TERATROFO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3