Nonsmall-cell Lung CancerPhase 1RNENCT06209229

Role of Neutrophils and Electro-bioluminescence in the Rehabilitation

A Phase 1 study testing sodium nucleinate in people with Nonsmall-cell Lung Cancer, run by MIPO Clinic at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Nonsmall-cell Lung Cancer
What is being tested?: sodium nucleinate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteKazakhstan
Study dates: 1 May 2022to 1 Oct 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 20Show fewer

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 locations and contacts

1 site in 1 country.

Kazakhstan1 site

MIPOClinic
Almaty, 050038

Other trials in Kazakhstan

About this study

Official title: Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)

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.

Read the 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.

Conditions: Nonsmall-cell Lung Cancer
Being tested: sodium nucleinate
Keywords: integrative medicine, macrophages, Therapeutic Phase Of Medical Rehabilitation, Non-Small Cell Lung Cancer, sodium nucleinate, Neutrophil dysfunction test
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sodium nucleinateBiological
Also called cholecalciferol, pyridoxine hydrochloride, quercetin, magnesium lactate dihydrate
- 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.

Study groups in NCT06209229
Study group	Role	What they receive
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. Receives: Biological: sodium nucleinate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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
Morphologic blood analysis with determination of the number of segmented neutrophils, basophils, monocytes and lymphocytes according to the standard of operating procedures " Total blood analysis"
Measured: 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
Functional blood analysis with determination of phagocytic activity of granulocytes with 1.5 μm latex and counting by a laboratory assistant of 200 cells in the ratio of stained and unstained cells in the field of lifetime light microscopy
Measured: 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
Functional blood analysis with determination of liposomal activity of granulocytes by qualitative reaction to nitroblue tetrazolium and counting by a laboratory assistant of 200 cells in the ratio of stained and unstained cells in the field of lifetime light microscopy
Measured: 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
Functional blood analysis with determination of plastic activity of granulocytes by qualitative reaction to extra-nuclear RNA by staining with acridine orange and counting of 200 cells in the ratio of stained and unstained cells in the field of lifetime luminescent microscopy
Measured: 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
Functional blood analysis with determination of mitochondrial activity of granulocytes by qualitative reaction for extra-nuclear DNA by staining with acridine orange and counting 200 cells in the ratio of stained and unstained cells in the field of lifetime luminescence microscopy by a laboratory technician
Measured: 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
Functional blood analysis of granulocyte membrane dysfunction by qualitative reaction to membrane damage by staining the cytoplasm with ethidium bromide and counting by a laboratory technician 200 cells in the ratio of stained to unstained cells in the field of lifetime luminescence microscopy
Measured: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20221 Oct 2023

First posted17 Jan 2024
Study start1 May 2022
Primary completion1 May 2023
Study completion1 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nonsmall-cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06209229
Sponsor's protocol ID: 2
Acronym: RNE
Status last verified: Jan 2024
First submitted: 17 Dec 2023
Last updated: 17 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nonsmall-cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Neutrophils and Electro-bioluminescence in the Therapeutic Stage of Medical Rehabilitation of Some Oncologic Diseases (Pilot Project)
ClinicalTrials.gov ID: NCT06209229
Acronym / sponsor ID: RNE / 2
Conditions: Nonsmall-cell Lung Cancer
Keywords: integrative medicine, macrophages, Therapeutic Phase Of Medical Rehabilitation, Non-Small Cell Lung Cancer, sodium nucleinate, Neutrophil dysfunction test
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: MIPO ClinicUniversity, hospital or other
Study start: 1 May 2022 (actual)
Primary completion: 1 May 2023 (actual)
Study completion: 1 Oct 2023 (actual)
First posted: 17 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Scientific novelty: previously such studies have not been conducted in Kazakhstan.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
natirium nucleonate	Experimental	Biological: sodium nucleinate* 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.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (20 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sodium nucleinateAlso: cholecalciferol, pyridoxine hydrochloride, quercetin, magnesium lactate dihydrate* 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	natirium nucleonate

Primary outcome

scoring of completed quality-of-life tests
Time frame: 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.
survival rate
Time frame: 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
determination of stress level and adaptation reserves of the organism
Time frame: 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.

6 secondary outcomes

Total clinical morphologic blood tests
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arai Tolemisova, PhD study chair

MIPO Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sodium nucleinate in people with Nonsmall-cell Lung Cancer, run by MIPO Clinic at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

scoring of completed quality-of-life tests (time frame: Before the start of the intervention, on day 22 after the start of the intervention, and after 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06209229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.