Clinical trial NCT06209229: Role of Neutrophils and Electro-bioluminescence in the Rehabilitation
Official title: Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonsmall-cell Lung Cancer
Keywords: integrative medicine
macrophages
Therapeutic Phase Of Medical Rehabilitation
Non-Small Cell Lung Cancer
sodium nucleinate
Neutrophil dysfunction test
Lead sponsor: MIPO Clinic
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: scoring of completed quality-of-life tests
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: survival rate
timeFrame: after 1 year
measure: determination of stress level and adaptation reserves of the organism
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Secondary outcomes:
measure: Total clinical morphologic blood tests
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: A functional blood test to determine phagocytosis
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: Functional blood analysis with determination of liposomal activity of granulocytes
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: Functional blood analysis with determination of plastic activity of granulocytes
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: Functional blood analysis of mitochondrial dysfunction
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
measure: Functional blood analysis of granulocyte membrane dysfunction
timeFrame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: MIPOClinic
Study officials:
affiliation: MIPO Clinic
name: Arai Tolemisova, PhD
role: STUDY_CHAIR
References: