Clinical trial NCT05472753: Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: intestinal microbiota,
antioxidants
anti-inflammatories
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the alpha diversity index (Shannon)
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary outcomes:
measure: Change in weight
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Change in height
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: BMI (body mass index) changes
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Mediterranean diet adherence questionnaire
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Maximum and mean value of 3 measurements in dominant hand dynamometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Maximum and mean value of 3 measurements in non dominant hand dynamometrydynamometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Mean dominant arm circumference
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Calf circumference in the dominant leg
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Anteroposterior diameter of the rectus femoris of the quadriceps in the dominant thigh
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Transverse diameter of the rectus femoris of the quadriceps in the dominant thigh
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Cross-sectional area of the rectus femoris quadriceps in the dominant thigh
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Transverse perimeter of the quadriceps rectus muscle in the dominant thigh
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Mean value of 3 measurements of the anteroposterior diameter of abdominal subcutaneous adipose tissue
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Mean value of 3 measurements of the anteroposterior diameter of abdominal visceral adipose tissue
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Fat mass in bioimpedanciometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Lean mass in bioimpedanciometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Extracellular water in bioimpedanciometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Phase angle 50 kHz in bioimpedance measurement
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Total cell mass in bioimpedance measurement
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Appendicular muscle mass in bioimpedanciometry
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Percentage of weight lost in the last 6 months
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Percentage of weight lost in the last 12 months
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Hemoglobin in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Mean corpuscular volume in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Leukocytes in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Lymphocytes in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Platelets in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Creatinine in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Glucose in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Sodium in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Potassium in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Chlorine in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Calcium in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Phosphorus in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Magnesium in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Iron in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Blood cholesterol
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: HDL cholesterol in the blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: LDL cholesterol in the blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Blood triglycerides
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: ALT in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: GGT in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Alkaline phosphatase in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Bilirubin in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Total protein in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Albumin in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Ferritin in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: 25OH vitamin D in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Prealbumin in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: C-reactive protein in blood
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Normalized prothrombin time
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Degree in "ECOG Performance Status Scale"
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Assess the effect of supplementation on quality of life: "EORTC QLQ-30" test.
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Assess the effect of supplementation on quality of life: "EORTC QLQ-CR29" test.
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Assess the effect of supplementation on symptoms of depression-anxiety
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Assess gastrointestinal tolerance to supplementation and chemotherapy
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Change in serum C-reactive protein
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Change in serum Il-6
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Change in serum TNF-alpha
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
measure: Change in stool calprotectin
timeFrame: From baseline to 3 months about 2 weeks after starting chemotherapy
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga, FIMABIS
name: Gabriel Olveira Fuster, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: