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

MIPO Clinic

Status and phase: Completed; Phase 1

Conditions: Nonsmall-cell Lung Cancer

Treatments: Biological: sodium nucleinate

Study type: Interventional

Funder types: Other

Identifiers

NCT06209229

2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

natirium nucleonate

Experimental group

Description:

* 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.

Treatment:

Biological: sodium nucleinate