Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- survival rate
研究概览
简要总结
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:
- does the quality of life of patients with lung cancer change with the use of a course of immunomodulatory drugs and detoxification scheme?
- does phagocytosis function, liposomal activity, mitochondrial function of neutrophils change against the background of the course?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
survival rate
时间窗: after 1 year
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
scoring of completed quality-of-life tests
时间窗: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
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.
determination of stress level and adaptation reserves of the organism
时间窗: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year
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.
次要结局
- 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 of mitochondrial dysfunction(Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year)
- Total clinical morphologic blood tests(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 granulocyte membrane dysfunction(Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year)