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Colon CancerTERATROFONCT05472753

Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer

A study testing Experimental Treatment, DCOOP Product, Hydroxytyrosol extract and Experimental Treatment,Indukern product, Curcumin and selenium extract in people with Colon Cancer, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colon Cancer
What is being tested?
Experimental Treatment, DCOOP Product, Hydroxytyrosol extract and Experimental Treatment,Indukern product, Curcumin and selenium extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteSpain
Study dates
16 Nov 2022to 31 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Regional Universitario de Málaga

    Málaga, Málaga, 29009

Other trials in Spain

About this study

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.

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

Read the 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.

Conditions
Colon Cancer
Being tested
Experimental Treatment, DCOOP Product, Hydroxytyrosol extract, Experimental Treatment,Indukern product, Curcumin and selenium extract, Control Treatment
Keywords
intestinal microbiota,, antioxidants, anti-inflammatories
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental Treatment, DCOOP Product, Hydroxytyrosol extractDietary supplement

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

  • Experimental Treatment,Indukern product, Curcumin and selenium extractDietary supplement

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

  • Control TreatmentOther

    Control group will receive a placebo (product loading substance)

Study groups in NCT05472753
Study groupRoleWhat they receive
Group 1 (25 patients)ExperimentalA product of the company DCOOP, with hydroxytyrosol extract
Receives: Dietary Supplement: Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
Group 2 (25 patients)ExperimentalA product of the company Indukern, with extract of curcumin and selenium
Receives: Dietary Supplement: Experimental Treatment,Indukern product, Curcumin and selenium extract
Group 3 (25 patients)Placebo comparatorPlacebo
Receives: Other: Control Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (60)

  1. Change in weight

    Weight in kg

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

  2. Change in height

    Height in m

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

  3. BMI (body mass index) changes

    Measured by body composition analysis

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

  4. 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.

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

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

    Measured in kg

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

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

    Measured in kg

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

  7. Mean dominant arm circumference

    Measured in cm

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

  8. Calf circumference in the dominant leg

    Measured in cm

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

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

    Measured in cm

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

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

    Measured in cm

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

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

    Measured in in cm²

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

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

    Measured in cm

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

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

    Measured in cm

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

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

    Measured in cm

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

  15. Fat mass in bioimpedanciometry

    Measured in kg

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

  16. Lean mass in bioimpedanciometry

    Measured in kg

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

  17. Extracellular water in bioimpedanciometry

    Measured in kg

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

  18. Phase angle 50 kHz in bioimpedance measurement

    Measured in º

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

  19. Total cell mass in bioimpedance measurement

    Measured in kg

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

  20. Appendicular muscle mass in bioimpedanciometry

    Measured in kg

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

  21. Percentage of weight lost in the last 6 months

    Measured in %.

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

  22. Percentage of weight lost in the last 12 months

    Measured in %.

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

  23. Hemoglobin in blood

    Measured in g/dl

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

  24. Mean corpuscular volume in blood

    Measured in in fL

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

  25. Leukocytes in blood

    Measured in in x10^9/l

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

  26. Lymphocytes in blood

    Measured in in x10^9/l

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

  27. Platelets in blood

    Measured in in x10^9/l

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

  28. Creatinine in blood

    Measured in in g/dl

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

  29. Glucose in blood

    Measured in in mg/dl

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

  30. Sodium in blood

    Measured in mEq/l

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

  31. Potassium in blood

    Measured in mEq/l

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

  32. Chlorine in blood

    Measured in mEq/l

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

  33. Calcium in blood

    Measured in in mg/dl

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

  34. Phosphorus in blood

    Measured in in mg/dl

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

  35. Magnesium in blood

    Measured in in mg/dl

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

  36. Iron in blood

    Measured in in mcg/dl

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

  37. Blood cholesterol

    Measured in in mg/dl

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

  38. HDL cholesterol in the blood

    Measured in in mg/dl

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

  39. LDL cholesterol in the blood

    Measured in in mg/dl

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

  40. Blood triglycerides

    Measured in in mg/dl

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

  41. ALT in blood

    Measured in U/L

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

  42. GGT in blood

    Measured in U/L

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

  43. Alkaline phosphatase in blood

    Measured in U/L

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

  44. Bilirubin in blood

    Measured in mg/dl

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

  45. Total protein in blood

    Measured in g/dl

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

  46. Albumin in blood

    Measured in g/dl

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

  47. Ferritin in blood

    Measured in ng/ml

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

  48. 25OH vitamin D in blood

    Measured in ng/ml

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

  49. Prealbumin in blood

    Measured in mg/dl

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

  50. C-reactive protein in blood

    Measured in mg/dl

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

  51. Normalized prothrombin time

    Measured in in INR

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

  52. 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.

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

  53. 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.

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

  54. 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.

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

  55. 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.

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

  56. 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.

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

  57. Change in serum C-reactive protein

    Measured in mg/l

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

  58. Change in serum Il-6

    Measured in pg/ml

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

  59. Change in serum TNF-alpha

    Measured in pg/ml

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

  60. Change in stool calprotectin

    Measured in mcg/g

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start16 Nov 2022
  3. Primary completion27 Feb 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized in a 1:1 ratio
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472753
Sponsor's protocol ID
TERATROFO
Acronym
TERATROFO
Status last verified
Feb 2025
First submitted
4 May 2022
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Treatment, DCOOP Product, Hydroxytyrosol extract and Experimental Treatment,Indukern product, Curcumin and selenium extract in people with Colon Cancer, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the alpha diversity index (Shannon) (time frame: From baseline to 3 months about 2 weeks after starting chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05472753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

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