Colon Cancer
Conditions
Interventions
Group A (control): chemotherapy (QT) FOLFOX OR CAPEOX, (intravenous administration) + placebo, in the same way as group B.
Group B (experimental): FOLFOX or CAPEOX chemotherapy, (intravenous administr
Dietary Supplements
Placebos
Administration, Oral
Administration, Intravenous
Metabiotic Del-Immune V
Sponsors
Hermanos Ameijeiras Clinical Surgical Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 - Patients of any sex, residents in Cuba, aged 18 years or older. 2 - Patients who meet the diagnostic criteria. 3 - Patients with a general state of health according to Karnofsky =70%. 4 - Life expectancy greater than or equal to 3 months. 5 - Patients eligible to receive chemotherapy scheme FOLFOX-IV, XELOX or XELIRI. 6 - Patients who have signed the informed consent. 7 - Patients who have laboratory values ??in parameters that do not contraindicate the administration of chemotherapy: - Hemoglobin = 90 g/l - Total Leukocyte Count = 3.0 x 109 /L - Absolute Neutrophil Count =1.5 x 109 /L - Platelet count =100 x 109 /L - Total bilirubin values ??= 1.5 times the upper limit of the normal range established in the institution. - OGRT and OGT values ??=2.5 times the upper limit of the normal range established in the institution. - Creatinine values ??within the normal limits of the institution.
Exclusion criteria
Exclusion criteria: 1 - Pregnant or lactating patients 2 - Patients with known hypersensitivity to 5-Fluoracil, Folinic Acid, Oxaliplatin, Capecitabine or Irinotecan. 3 - Patients who are receiving another investigational product. 4 - Patients with intercurrent decompensated diseases, including: AHT, Diabetes Mellitus, Ischemic Cardiopathy, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that, at the doctor's discretion, puts their health at risk and your life during the study or your participation in the trial. 5 - Patients with brain metastases. 6 - Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammatory biomarker levels. IL-6 (will be measured in PG/ML), C-reactive protein (will be measured in mg/L), CEA tumor marker (will be measured in ng/mL). Measurement time: basal, 15 days, week 12, week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (EORTC QLQ-CR30 Quality of Life Survey). Measurement time: baseline, 15 days, week 12, week 24 and 2 months after the end of treatment. Overall Survival (It is the time from the date of diagnosis to the date of last news or death). Measurement time: as survival rates one year, three years and five years after the study has concluded. Disease-Free Survival (Time from the start of treatment to the date of evidence of disease relapse) Measurement time: as disease-free survival rates one year, three years, and five years after the end of the study. Toxicity: (Type of adverse event, severity, causal relationship). Measurement time: baseline, 15 days, week 12, week 24 and 2 months after the end of treatment. | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
Hermanos Ameijeiras Clinical Surgical Hospital
Outcome results
None listed