MIPOClinic
Almaty, 050038, Kazakhstan
NCT Number: NCT06209229
The clinical study is to find out the effect of a course of immunomodulatory drugs and detoxification scheme on finger bioelectroluminescence and neutrophil function and their correlation with changes in quality of life and life expectancy in patients with malignant diseases against the background of restorative treatment and rehabilitation.
Questions:
1. does the quality of life of patients with lung cancer change with the use of a course of immunomodulatory drugs and detoxification scheme? 2. does phagocytosis function, liposomal activity, mitochondrial function of neutrophils change against the background of the course? 3. does bioluminescence of fingers of hands change against the background of the course of immunotherapy? Participants will take Calcitreol capsules, Magnesium B-6 capsules, products containing quercetin flavonoids, Naderin (sodium deoxeribonucleate) daily for 21 days. before the course, after the course and after one year they will answer the QLQ-LC13, WHOQOL BREF, L.H. Garkavi adaptation self-assessment questionnaire and give blood for laboratory analysis of neutrophil function assessment.
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Notify Me40 year–65 year
All sexes
Interventional
Phase 1
Almaty, 050038, Kazakhstan
Every year, 36,000 new cases of oncology are detected in Kazakhstan, and 14,150 people (39.3%) die from oncology in Kazakhstan each year. The lowest five-year survival rate for patients with lung cancer is 12.6%. Today, an important criterion in choosing a treatment method for oncologic diseases is the level of quality of life corresponding to the treatment performed. To assess this level, special questionnaires and scales are also developed, for example, QLQ-C30 (the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0), which appeared thanks to the separation and expansion of the GHRQL (global health-related quality of life) questionnaire. In addition to quality of life, it is very important to improve life expectancy by increasing the adaptive reserves of the organism and preventing complications. To achieve this goal it is necessary to conduct oncologic rehabilitation and course reconstructive therapy for patients with lung cancer with prevention of fiborosis development. To assess the quality of life in dynamics, it is necessary to interview patients using international questionnaires. And for objective assessment of changes in adaptation reserves it is planned to check the effectiveness of the method of functional assessment of neutrophils, bioelectroluminescence in comparison with the generally recognized neutrophil/lymphocyte index. Important in the work is the mutual control of the obtained clinical indicators with the patient's experience and his assessment of changes in the quality of life on the background of the received therapy. The expected result of the study is an increase in the average annual survival rate of patients and improved quality of life. Creation of a responsive health care system to the needs of patients.
Scientific novelty: previously such studies have not been conducted in Kazakhstan.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: cholecalciferol, pyridoxine hydrochloride, quercetin, magnesium lactate dihydrate
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Patients will be given 3 quality of life questionnaires to complete: EORTC QLQ - LC13 Lung Cancer Specific Quality of Life Questionnaire, WHOQOL Brief Quality of Life Questionnaire (WHOQOL BREF), L.H. Garkavi Adaptation Self-Efficacy Questionnaire.
Time frame: after 1 year
Estimation of the number of patients who survived a year of rehabilitation compared to the average survival rates of public health care in the Republic of Kazakhstan
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Assessment of stress level and functional adaptation reserves of the organism by bioelectrography on the GRV-camera with analysis of gas-electric photographs of the fingers of the hand in the Bio-Well program according to the following indicators: area of luminescence, normalized area, intensity of luminescence, radius of the circle inscribed in the inner oval, luminescence shape coefficient and internal noise.
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Morphologic blood analysis with determination of the number of segmented neutrophils, basophils, monocytes and lymphocytes according to the standard of operating procedures " Total blood analysis"
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis with determination of phagocytic activity of granulocytes with 1.5 μm latex and counting by a laboratory assistant of 200 cells in the ratio of stained and unstained cells in the field of lifetime light microscopy
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis with determination of liposomal activity of granulocytes by qualitative reaction to nitroblue tetrazolium and counting by a laboratory assistant of 200 cells in the ratio of stained and unstained cells in the field of lifetime light microscopy
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis with determination of plastic activity of granulocytes by qualitative reaction to extra-nuclear RNA by staining with acridine orange and counting of 200 cells in the ratio of stained and unstained cells in the field of lifetime luminescent microscopy
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis with determination of mitochondrial activity of granulocytes by qualitative reaction for extra-nuclear DNA by staining with acridine orange and counting 200 cells in the ratio of stained and unstained cells in the field of lifetime luminescence microscopy by a laboratory technician
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis of granulocyte membrane dysfunction by qualitative reaction to membrane damage by staining the cytoplasm with ethidium bromide and counting by a laboratory technician 200 cells in the ratio of stained to unstained cells in the field of lifetime luminescence microscopy
MIPO Clinic
Other
Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)
Acronym: RNE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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