Role of Neutrophils and Electro-bioluminescence in the Rehabilitation

NCT06209229 | Completed Phase 1

• 1 other identifier: 2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.does phagocytosis function, liposomal activity, mitochondrial function of neutrophils change against the background of the course?
3. 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.

Conditions

Nonsmall-cell Lung Cancer

Keywords

integrative medicine; macrophages; Therapeutic Phase Of Medical Rehabilitation; Non-Small Cell Lung Cancer; sodium nucleinate; Neutrophil dysfunction test

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Total clinical morphologic blood tests

  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

  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

  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

  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

  Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year

Study Arms (1)

natirium nucleonate

EXPERIMENTAL

* 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

Interventions

sodium nucleinate BIOLOGICAL

* 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.

Also known as: cholecalciferol, pyridoxine hydrochloride, quercetin, magnesium lactate dihydrate

natirium 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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MIPO Clinic: lead

Study Sites (1)

MIPOClinic

Almaty, 050038, Kazakhstan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sodium nucleinate; Cholecalciferol; Pyridoxine; Quercetin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arai Tolemisova, PhD

  MIPO Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Independent sequential randomization of patients admitted over short periods of time into treatment groups will be conducted. Study participants will be recruited as patients present to the clinic, up to a maximum of 12 patients per week. Each patient included in the study will be assigned an ordinal number sequentially according to a table of a random sequence. For the purpose of blinding, the number will be assigned by the registrar of the admission department and will not be further involved in the study. The intake nurse and the researcher will not know the patient's chart except for the assigned number. The physician performing the examination and prescribing therapy will not know the results of the functional assessment of blood and GFR. The results will be entered into the subject's chart at the end of the course of treatment and supplemented by a follow-up examination after 12 months. Blinded follow-up
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon's two-stage plan will be used (Simon R (1989). Controlled Clinical Trials 10: 1-10.). The first stage will test the Null Hypothesis that the true response rate is \[p0=0.4\] will be tested against the one-sided alternative hypothesis. In the first stage, \[n0=16\] patients will be recruited. If these \[n1=34\] patients have \[r1=17\] or fewer responses, the study will be stopped. Otherwise, \[n - n1=39-34=5\] additional patients will be accrued, totaling \[n=39\]. In the second step, the Null Hypothesis will be rejected if \[r2 + 1= 20+1\] or more responses are observed in \[n=39\] patients. This plan yields a Type I error rate \[Type I error rate=0.05\] and power \[w=0.8\] when the true response rate is \[p1=0.6\]. Patients will be followed up for 1 year

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)