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Completed

NCT Number: NCT05472753

Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Treatment, DCOOP Product, Hydroxytyrosol extract

Dietary Supplement

Intervention group will receive a nutritional formula from DCOOP (Spain).

Experimental Treatment,Indukern product, Curcumin and selenium extract

Dietary Supplement

Intervention group will receive a nutritional formula from Indukern (Spain).

Control Treatment

Other

Control group will receive a placebo (product loading substance)

Primary outcomes

  1. Change in the alpha diversity index (Shannon)

    Time frame: 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.

Secondary outcomes

  1. Change in weight

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Weight in kg

  2. Change in height

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Height in m

  3. BMI (body mass index) changes

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured by body composition analysis

  4. Mediterranean diet adherence questionnaire

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    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.

  5. Maximum and mean value of 3 measurements in dominant hand dynamometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  6. Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  7. Mean dominant arm circumference

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  8. Calf circumference in the dominant leg

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  9. Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  10. Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  11. Cross-sectional area of the rectus femoris quadriceps in the dominant thigh

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in cm²

  12. Transverse perimeter of the quadriceps rectus muscle in the dominant thigh

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  13. Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  14. Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in cm

  15. Fat mass in bioimpedanciometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  16. Lean mass in bioimpedanciometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  17. Extracellular water in bioimpedanciometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  18. Phase angle 50 kHz in bioimpedance measurement

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in º

  19. Total cell mass in bioimpedance measurement

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  20. Appendicular muscle mass in bioimpedanciometry

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in kg

  21. Percentage of weight lost in the last 6 months

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in %.

  22. Percentage of weight lost in the last 12 months

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in %.

  23. Hemoglobin in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in g/dl

  24. Mean corpuscular volume in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in fL

  25. Leukocytes in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in x10^9/l

  26. Lymphocytes in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in x10^9/l

  27. Platelets in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in x10^9/l

  28. Creatinine in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in g/dl

  29. Glucose in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  30. Sodium in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mEq/l

  31. Potassium in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mEq/l

  32. Chlorine in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mEq/l

  33. Calcium in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  34. Phosphorus in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  35. Magnesium in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  36. Iron in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mcg/dl

  37. Blood cholesterol

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  38. HDL cholesterol in the blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  39. LDL cholesterol in the blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  40. Blood triglycerides

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in mg/dl

  41. ALT in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in U/L

  42. GGT in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in U/L

  43. Alkaline phosphatase in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in U/L

  44. Bilirubin in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mg/dl

  45. Total protein in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in g/dl

  46. Albumin in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in g/dl

  47. Ferritin in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in ng/ml

  48. 25OH vitamin D in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in ng/ml

  49. Prealbumin in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mg/dl

  50. C-reactive protein in blood

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mg/dl

  51. Normalized prothrombin time

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in in INR

  52. Degree in "ECOG Performance Status Scale"

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    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.

  53. Assess the effect of supplementation on quality of life: "EORTC QLQ-30" test.

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    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.

  54. Assess the effect of supplementation on quality of life: "EORTC QLQ-CR29" test.

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    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.

  55. Assess the effect of supplementation on symptoms of depression-anxiety

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    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.

  56. Assess gastrointestinal tolerance to supplementation and chemotherapy

    Time frame: From baseline to 3 months about 2 weeks after starting 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.

  57. Change in serum C-reactive protein

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mg/l

  58. Change in serum Il-6

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in pg/ml

  59. Change in serum TNF-alpha

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in pg/ml

  60. Change in stool calprotectin

    Time frame: From baseline to 3 months about 2 weeks after starting chemotherapy

    Measured in mcg/g

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Acronym: TERATROFO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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