Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509880
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Immunosurveillance for Metastatic Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISMCC
Brief Summary:
The goal of this study type clinical trial is to primary purpose eg 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 questions it aims to answer isare
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 theyll 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
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 theyll 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 CD4CD8 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 70 for Windows StatSoft USA The Mann-Whitney U-criterion was used to compare the studied samples by qualitative indicators
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 CD4CD8 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 70 for Windows StatSoft USA The Mann-Whitney U-criterion was used to compare the studied samples by qualitative indicators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None