Role of Neutrophils and Electro-bioluminescence in the Rehabilitation
Condition: Nonsmall-cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): sodium nucleinate
Intervention type(s): Biological
Intervention description(s): 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 intervention name(s): cholecalciferol; pyridoxine hydrochloride; quercetin; magnesium lactate dihydrate
Intervention MeSH terms: Cholecalciferol; Pyridoxine; Vitamin B 6; Sodium nucleinate; Quercetin
Intervention model: Single Group Assignment
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
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: integrative medicine; macrophages; Therapeutic Phase Of Medical Rehabilitation; Non-Small Cell Lung Cancer; sodium nucleinate; Neutrophil dysfunction test