Trial Title:
Immunosurveillance for Metastatic Colorectal Cancer
NCT ID:
NCT06509880
Condition:
Monitoring, Immunologic
Conditions: Official terms:
Colorectal Neoplasms
Sodium nucleinate
Conditions: Keywords:
Colorectal Cancer
Chemotherapy
Rehabilitation
Mitochondria
Sodium Nucleinate
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Adenorine
Description:
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.
Arm group label:
Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate
Other name:
natural oligodeoxynucleotide
Other name:
sodium nucleinate
Intervention type:
Biological
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Chemotherapy according to the FOLFOX regimen
Intervention type:
Drug
Intervention name:
FOLFOX regimen
Description:
(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)
Arm group label:
Chemotherapy according to the FOLFOX regimen
Arm group label:
Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate
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.
Detailed description:
Materials and methods of the study. According to the approved by the Local Ethical
Committee of the Kazakh National Medical University, it was planned to include in the
study 200 patients from 19 regions of Kazakhstan with histological, verified diagnosis of
"colorectal cancer", treated in oncological centers of 4 regions of Kazakhstan, where
there were University Clinics.
Distribution of Colorectal Cancer Patients (CRC) by Type of Treatment.
1. Main group - Chemotherapy according to the FOLFOX regimen in combination with sodium
nucleonate 100
2. Control group Chemotherapy according to the FOLFOX regimen 100 Study Design The
study design included an evaluation of the effectiveness of FOLFOX chemotherapy in
combination with sodium nucleinate immunotherapy in 187 patients with metastatic
colorectal cancer at stages T3-4 N1-2 M1. Randomization into two groups-main and
control-was performed using the envelope method.
The main group included 89 patients with metastatic colorectal cancer (stages T3-4 N1-2
M), receiving four courses of FOLFOX chemotherapy 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.
The control group consisted of 98 patients with metastatic colorectal cancer (stages T3-4
N1-2 M), who received only four courses of FOLFOX chemotherapy. In both groups, general
and biochemical blood analyses were conducted monthly.
Additionally, before the start of treatment and one month after the end of treatment,
PET-CT scans were performed, levels of tumour markers CEA and CA-19-9 were determined,
immunological status CD4/CD8 and mitochondrial activity of neutrophils were assessed, and
echocardiography was conducted to determine the left ventricular ejection fraction. A
well-being questionnaire (the European Organization for Research and Treatment of Cancer
(EORTC) QLQ-CR29) was also administered.
Critical Points
1. Reduction in treatment interruptions due to leukopenia, neutropenia, and infectious
complications during chemotherapy for metastatic colorectal cancer (CRC).
2. Increased percentage of tumour process stabilization during palliative chemotherapy
for CRC.
Reduction in one-year mortality during palliative treatment of metastatic CRC.
Statistical analysis of the study results was performed using the application program
package "Statistica 7.0" for Windows (StatSoft, USA). The Mann-Whitney U-criterion was
used to compare the studied samples by qualitative indicators.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. 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.
Exclusion Criteria:
1. 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.
2. 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.
Gender:
All
Minimum age:
40 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
MIPOClinic
Address:
City:
Almaty
Zip:
050038
Country:
Kazakhstan
Start date:
July 15, 2024
Completion date:
July 31, 2024
Lead sponsor:
Agency:
MIPO Clinic
Agency class:
Other
Source:
MIPO Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06509880
