Immunosurveillance for Metastatic Colorectal Cancer
NCT Number: NCT06509880
Acronym: ISMCC
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Monitoring, Immunologic
Interventions: DIETARY_SUPPLEMENT: Adenorine|BIOLOGICAL: Placebo|DRUG: FOLFOX regimen
Sponsor: MIPO Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-07-31
Locations: MIPOClinic, Almaty, 050038, Kazakhstan

Summary:
The goal of this study type: clinical trial is to primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc. and improve the quality of life and reduce one-year mortality in palliative treatment of metastatic forms of colorectal cancer.. The main question\[s\] it aims to answer \[is/are\]:

1. Does the combination of sodium adenosine nucleonate and FOLFOX course affect chemotherapy efficacy and treatment adherence?
2. which of the assays can be considered a marker of the efficacy of the combination of sodium nucleonate and FOLFOX?
3. Effect of the combination of adenosine nucleonate sodium and FOLFOX on patient quality of life?

   * If there is a comparison group:_ Researchers will compare \[compare the two arms of the main arm 100 patients and the control arm 100 patients\] to see if \[insert effects\].

Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

1. To evaluate the efficacy of palliative care with 4 courses of FOLFOX-based chemotherapy combined with sodium nucleonate for metastatic colorectal cancer (CRC) in the main group.
2. In the control group in metastatic colorectal cancer to study the efficacy of 4 courses of stand-alone standard chemotherapy according to the FOLFOX scheme.
3. To examine the obtained results and compare the quality of life, dynamics of laboratory tests and overall survival in the main and control groups.
4. To evaluate the influence of quantitative and qualitative indices of mitochondrial activity in the blood of patients in the main and control groups.
5. To reveal the correlation between the dynamics of mitochondrial dysfunction, quality of life of patients, tolerance to toxic effects of chemotherapy, as well as the reduction of one-year mortality in patients with colorectal cancer.

Primary Outcome Measures: EORTC QLQ-CR29, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR29 max242 min59. whether higher scores mean a worse outcome, before the start of treatment and one month after the end of treatment|Dynamics of mitochondrial activity neutrophils, Mitochondrial dynamics refers to the changing process of fission, fusion, mitophagy and transport, which is crucial for optimal function in signal transduction and metabolism. An imbalance in mitochondrial dynamics can disrupt mitochondrial function, leading to abnormal cellular fate, and a range of diseases, including neurodegenerative disorders, metabolic diseases, cardiovascular diseases and cancers. Herein, we review the mechanism of mitochondrial dynamics, and its impacts on cellular function. the normal range of cell distribution 30-60% 30% of the 200 cells counted. whether higher scores mean a better outcome., before the start of treatment and one month after the end of treatment|Positron emission tomography/computed tomography, Positron emission tomography (PET/CT) is used prior to surgery in patients with metastatic or recurrent colorectal cancer to identify those with potentially curable disease or to dynamically monitor the course of the disease. normally, it does not accumulate an isotope. whether higher scores mean a worse outcome., before the start of treatment and one month after the end of treatment|CEA, Carcinoembryonic Antigen Oncomarker is used in the diagnosis of malignant and benign tumors of GI organs or to dynamically monitor the course of the disease. normal concentration min=0 ng/ml max=5,5 ng/ml. whether higher scores mean a worse outcome., before the start of treatment and one month after the end of treatment|CA 19-9 (Carbohydrate (carbohydrate) antigen 19-9), CA 19-9 was discovered in the early 1980s by researchers working to identify tumor antigens in colorectal cancer or to dynamically monitor the course of the disease. normal concentration min=0 U/ml, max=27,0 U/ml. whether higher scores mean a worse outcome., before the start of treatment and one month after the end of treatment|CD4/ CD8 ratio, Prognostic value of the CD4+/CD8+ ratio of tumour infiltrating lymphocytes in colorectal cancer. The normal range of CD4+/CD8+ is from 1.0 to 4.0. the ratio level above and below the norm is considered a bad prognostic sign, before the start of treatment and one month after the end of treatment
Secondary Outcome Measures: Echocardiography with determination of left ventricular ejection fraction, Echocardiography with determination of left ventricular ejection fraction to detect impaired function of vital organs as a factor of exclusion from the study group. in the case of a violation of the vital function of the heart below normal parameters, it is a negative sign and the patient is subject to exclusion from the study., before the start of treatment