Effect of the metabiotic Del-Immune V during chemotherapy treatment in individuals with colon cancer.

Hermanos Ameijeiras Clinical Surgical Hospital0 个研究点目标入组 52 人开始时间: 2023年1月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

Hermanos Ameijeiras Clinical Surgical Hospital