An interventional study of Experimental Treatment, DCOOP Product, Hydroxytyrosol extract and Experimental Treatment,Indukern product, Curcumin and selenium extract in Colon Cancer, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 75 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A product of the company DCOOP, with hydroxytyrosol extract
Dietary Supplement: Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
A product of the company Indukern, with extract of curcumin and selenium
Dietary Supplement: Experimental Treatment,Indukern product, Curcumin and selenium extract
Placebo
Other: Control Treatment
Intervention group will receive a nutritional formula from DCOOP (Spain).
Intervention group will receive a nutritional formula from Indukern (Spain).
Control group will receive a placebo (product loading substance)
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in weight
Weight in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in height
Height in m
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
BMI (body mass index) changes
Measured by body composition analysis
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Maximum and mean value of 3 measurements in dominant hand dynamometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Mean dominant arm circumference
Measured in cm
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Calf circumference in the dominant leg
Measured in cm
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh
Measured in cm
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh
Measured in cm
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Cross-sectional area of the rectus femoris quadriceps in the dominant thigh
Measured in in cm²
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Transverse perimeter of the quadriceps rectus muscle in the dominant thigh
Measured in cm
Time frame: 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
Measured in cm
Time frame: 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
Measured in cm
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Fat mass in bioimpedanciometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Lean mass in bioimpedanciometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Extracellular water in bioimpedanciometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Phase angle 50 kHz in bioimpedance measurement
Measured in º
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Total cell mass in bioimpedance measurement
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Appendicular muscle mass in bioimpedanciometry
Measured in kg
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Percentage of weight lost in the last 6 months
Measured in %.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Percentage of weight lost in the last 12 months
Measured in %.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Hemoglobin in blood
Measured in g/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Mean corpuscular volume in blood
Measured in in fL
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Leukocytes in blood
Measured in in x10\^9/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Lymphocytes in blood
Measured in in x10\^9/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Platelets in blood
Measured in in x10\^9/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Creatinine in blood
Measured in in g/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Glucose in blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Sodium in blood
Measured in mEq/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Potassium in blood
Measured in mEq/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Chlorine in blood
Measured in mEq/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Calcium in blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Phosphorus in blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Magnesium in blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Iron in blood
Measured in in mcg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Blood cholesterol
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
HDL cholesterol in the blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
LDL cholesterol in the blood
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Blood triglycerides
Measured in in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
ALT in blood
Measured in U/L
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
GGT in blood
Measured in U/L
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Alkaline phosphatase in blood
Measured in U/L
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Bilirubin in blood
Measured in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Total protein in blood
Measured in g/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Albumin in blood
Measured in g/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Ferritin in blood
Measured in ng/ml
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
25OH vitamin D in blood
Measured in ng/ml
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Prealbumin in blood
Measured in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
C-reactive protein in blood
Measured in mg/dl
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Normalized prothrombin time
Measured in in INR
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
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.
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in serum C-reactive protein
Measured in mg/l
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in serum Il-6
Measured in pg/ml
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in serum TNF-alpha
Measured in pg/ml
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
Change in stool calprotectin
Measured in mcg/g
Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud