Role of Neutrophils and Electro-bioluminescence in the Rehabilitation (RNE)

Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)

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.

Study Overview

• Status: Completed
• Conditions: Nonsmall-cell Lung Cancer
• Intervention / Treatment: Biological: sodium nucleinate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, 050038
    • MIPOClinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis Non-small cell lung cancer (histologically verified)
• Must be able to swallow tablets
• Detected for the first time
• Presence of all fingers and toes
• Patient must give their informed and signed consent
• Patient must be insured or have a health insurance plan.
• Clinically stable patients regardless of disease type.
• Absence of cognitive impairment; since the protocol provides for a clinical interview covering in particular his/her quality of life

Exclusion Criteria:

• Decompensated forms of cancer (decompensation statuses of vital organs (pulmonary, cardiac, hepatic, renal, intestinal insufficiency);
• Clinical diagnosis other types of cancer, secondary tumors and lung metastases;
• Postoperative condition for lung tumor resection;
• Patient belongs to a vulnerable group;
• Patients with severe cognitive impairment;
• Tuberculosis of any localization in the active phase and in the anamnesis;
• Severe and decompensated course of endocrine diseases, including diabetes mellitus;
• Autoimmune diseases;
• Pregnancy and lactation period;
• Prisoners;
• Active military personnel;
• People without education;
• pensioners;
• People living below the poverty line or with limited access to health services.
• Unwillingness to participate in the study.
• Patient is participating in another study
• Patient with inability to complete our protocol evaluation scales
• Patients with symptoms that compromise their level of awareness
• Insulin dependent diabetes
• Thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: natirium nucleonate; Calcitriol- 5000 units in the morning before meals every other day 21 days and the next 3 weeks after the end of therapy.; Magnesium (in the form of lactate dihydrate) 470 mg + pyridoxine (in the form of hydrochloride) 5 mg - take orally 3 tablets per meter square of body surface area, in the evening 2 hours before bedtime, 21 days and the next 3 weeks after the end of therapy.; Quercetin from onion juice - take orally 1000 mg in the morning before meals, 21 days, as well as the next 3 weeks after the end of therapy.; sodium oligodinucleatide orally at the rate of 2 tablets under the tongue per meter square of body surface, in the morning 15 minutes before meals every other day, a total of 5 times (1, 3, 5, 7 , 9 day from the beginning of therapy), then after 21 days to repeat the course for 3 months.; Spray natirium nucleonate 4 doses in the morning on the hyoid, suck, do not swallow for 3-5 minutes, once every 4 days for 21 days.

Biological: sodium nucleinate; Calcitriol- 5000 units in the morning before meals every other day 21 days and the next 3 weeks after the end of therapy.; Magnesium (in the form of lactate dihydrate) 470 mg + pyridoxine (in the form of hydrochloride) 5 mg - take orally 3 tablets per meter square of body surface area, in the evening 2 hours before bedtime, 21 days and the next 3 weeks after the end of therapy.; Quercetin from onion juice - take orally 1000 mg in the morning before meals, 21 days, as well as the next 3 weeks after the end of therapy.; sodium oligodinucleatide orally at the rate of 2 tablets under the tongue per meter square of body surface, in the morning 15 minutes before meals every other day, a total of 5 times (1, 3, 5, 7 , 9 day from the beginning of therapy), then after 21 days to repeat the course for 3 months.; Spray natirium nucleonate 4 doses in the morning on the hyoid, suck, do not swallow for 3-5 minutes, once every 4 days for 21 days.; Other Names: cholecalciferol; quercetin; pyridoxine hydrochloride; magnesium lactate dihydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scoring of completed quality-of-life tests	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.	Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
survival rate	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	after 1 year
determination of stress level and adaptation reserves of the organism	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.	Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total clinical morphologic blood tests	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"	Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
A functional blood test to determine phagocytosis	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	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	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	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	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	Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Functional blood analysis of mitochondrial dysfunction	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	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	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	Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year

Collaborators and Investigators

• Sponsor: MIPO Clinic
• Investigators: Study Chair: Arai Tolemisova, PhD, MIPO Clinic

Publications and helpful links

Helpful Links

• New approaches to diagnosis and medical rehabilitation of malignant neoplasms at primary health care level: international project report
• Salidat Kairbekova National Scientific Center for Health Development

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; integrative medicine; macrophages; Therapeutic Phase Of Medical Rehabilitation; sodium nucleinate; Neutrophil dysfunction test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Micronutrients; Adjuvants, Immunologic; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anti-Ulcer Agents; Antioxidants; Vitamin B Complex; Interferon Inducers; Cholecalciferol; Quercetin; Vitamin B 6; Pyridoxine; Sodium nucleinate
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No