Immunosurveillance for Metastatic Colorectal Cancer

NCT06509880 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the combination of sodium adenosine nucleonate and FOLFOX course affect chemotherapy efficacy and treatment adherence?
2. 2.which of the assays can be considered a marker of the efficacy of the combination of sodium nucleonate and FOLFOX?
3. 3.Effect of the combination of adenosine nucleonate sodium and FOLFOX on patient quality of life?
4. 4.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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
5. 5.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.
6. 6.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.
7. 7.To examine the obtained results and compare the quality of life, dynamics of laboratory tests and overall survival in the main and control groups.
8. 8.To evaluate the influence of quantitative and qualitative indices of mitochondrial activity in the blood of patients in the main and control groups.
9. 9.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.

Conditions

Monitoring, Immunologic

Keywords

Colorectal Cancer; Chemotherapy; Rehabilitation; Mitochondria; Sodium Nucleinate

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Echocardiography with determination of left ventricular ejection fraction

  before the start of treatment

Study Arms (2)

Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate

ACTIVE COMPARATOR

Рatients with metastatic colorectal cancer (stages T3-4 N1-2 M), receiving four courses of FOLFOX chemotherapy (Day 1-2: Oxaliplatin 100 mg/m2 IV infusion, given as a 120 minutes IV infusion in 500 mL D5W, concurrent with leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2) IV infusion, followed by 5-FU 400 mg/m2 IV bolus, followed by 46-hour 5-FU infusion (2400 mg/m2 for first two cycles, and may be increased to 3000 mg/m2 if tolerated by patient (no toxicity \> grade 1 during the first two cycles), days 3-14: Rest days) combined with mitochondrial immunotherapy using sodium nucleinate. The medical rehabilitation protocol involved administering sodium nucleinate at 50 mg per day: 25 mg in the morning and 25 mg at lunch before meals, daily for four months.

Dietary Supplement: Adenorine; Drug: FOLFOX regimen

Chemotherapy according to the FOLFOX regimen

SHAM COMPARATOR

Рatients with metastatic colorectal cancer (stages T3-4 N1-2 M), who received only four courses of FOLFOX chemotherapy (Day 1-2: Oxaliplatin 100 mg/m2 IV infusion, given as a 120 minutes IV infusion in 500 mL D5W, concurrent with leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2) IV infusion, followed by 5-FU 400 mg/m2 IV bolus, followed by 46-hour 5-FU infusion (2400 mg/m2 for first two cycles, and may be increased to 3000 mg/m2 if tolerated by patient (no toxicity \> grade 1 during the first two cycles), days 3-14: Rest days). In both groups, general and biochemical blood analyses were conducted monthly

Biological: Placebo; Drug: FOLFOX regimen

Interventions

Adenorine DIETARY_SUPPLEMENT

The immunostimulating effect of the drug is associated with its ability to activate the cells of the monocyte-macrophage system, thus increasing the functional activity of all parts of the body, stimulating the repair and regeneration of cells and tissues. It reduces the symptoms of the iflammatory process, stimulates the development of granulations and growth of epithelial tissues, accelerates the process of cleansing and healing of infected wounds. While with healthy people, it can be used as a phylactic drug that improves immunity protection. It was proved that when the drug is used externally, activation of macrophages occurs, thus accelerating wound cleansing process and stimulating reparative processes. In cases when thermal injury to the skin is more than 15-20% of the surface, there is a "stress syndrome" that suppresses the immune system. When exposed to DNA-Na, lymphocyte activation occurs, wound cleansing processes are accelerated.

Also known as: natural oligodeoxynucleotide, sodium nucleinate

Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate

Placebo BIOLOGICAL

Placebo

Chemotherapy according to the FOLFOX regimen

FOLFOX regimen DRUG

(Day 1-2: Oxaliplatin 100 mg/m2 IV infusion, given as a 120 minutes IV infusion in 500 mL D5W, concurrent with leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2) IV infusion, followed by 5-FU 400 mg/m2 IV bolus, followed by 46-hour 5-FU infusion (2400 mg/m2 for first two cycles, and may be increased to 3000 mg/m2 if tolerated by patient (no toxicity \> grade 1 during the first two cycles), days 3-14: Rest days)

Chemotherapy according to the FOLFOX regimen; Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" and regional metastases at stages T1-4 N1-2 M0, who have provided informed consent to participate in the study.
• Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" with distant metastases at stages T1-4 N1-2 M1, who have provided informed consent to participate in the study.

You may not qualify if:

• Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" and regional metastases at stages T1-4 N1-2 M1, who have active forms of pulmonary tuberculosis, decompensated diabetes, decompensated cardiac, vascular, lung, liver, and renal failure.
• Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" with regional and distant metastases at stages T1-4 N1-2 M1, who have not provided informed consent to participate in the study.

Sponsors & Collaborators

• MIPO Clinic: lead

Study Sites (1)

MIPOClinic

Almaty, 050038, Kazakhstan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sodium nucleinate; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomized into two groups - main and control - using the envelope method. No surnames were indicated on the medical records. The researcher did not know to which group the patient would fall. The nurse did not know which group the patient was in when carrying out medical appointments. The physician-researcher was from another clinic and even from another city, who performed the laboratory analysis did not know the age, sex or diagnosis of the patient who was identified from the envelope. The social worker was from another clinic and when processing the results of the quality of life tests did not know to whom they belonged.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 19, 2024
• Study Start: July 15, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 31, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)