Slimming Myokines, Cancers,Nutritional and Psychology Support

NCT ID: NCT05278078

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-08-01

Brief Summary

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With the project investigators propose, investigators aim to find answers to the following questions: The fact that irisin and atropine are slimming the proteins that cause an increase in weight loss, and the excessive wasting (cachexia) in some types of cancer makes us wondering whether these factors may be cachectic factors for some GIS and US cancers? It is aimed to determine the relationship between irisin, atropine, some cachectic factors (PIF, ZAG), and cytokines (TNF-α, IL-1, IL-6) at tissue and plasma levels in these types of cancer. In addition, will psycho and nutrition education be applied to patients have an effect on cachexia? Experimental approaches to be used to find answers to such questions make this project unique.

Detailed Description

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Cancer is the excessive and uncontrolled proliferation of a group of cells in the body. Problems experienced in cancers (cachectic cancers) which are known to be more underweight than other types of cancer; nutritional deficiencies, increasing muscle and adipose tissue atrophy, and psychological problems accompanying cachexia. Weight loss is approximately 60-80% in some GIS and US cancers. Although the mechanism of weight loss in cancer has not been fully elucidated, the importance of proinflammatory cytokines (Tumor necrosis faktör-α (TNF-α), Interleukin-1 (IL-1), Interleukin-6 (IL-6) factors over-synthesized by the body and factors causing muscle and fat atrophy (Proteolysis inducing factors (PIF)and Zinc- α-2 glycoprotein (ZAG) released from tumor cells, is known, but new and more precise agents for the treatment of cachexia are under investigation.

With the project investigators propose, investigators aim to find answers to the following questions: The fact that irisin and adropin are slimming the proteins that cause an increase in weight loss, and the excessive wasting (cachexia) in some types of cancer makes us wonder whether these factors may be cachectic factors for some GIS and US cancers? It is aimed to determine the relationship between irisin, atropine, some cachectic factors (PIF, ZAG), and cytokines (TNF-α, IL-1, IL-6) at tissue and plasma levels in these types of cancer. In addition, will psychoeducation and nutrition education be applied to patients have an effect on cachexia? Experimental approaches to be used to find answers to such questions make this project unique.

In this project, first of all, irisin and atropine will be compared to a combination of cachectic factors and cytokines due to, whether the effect of irisin and atropine on the formation of cancer cachexia at the level of gene and protein in tissue and plasma samples taken from 240 patients diagnosed with GIS (gastric, colon) and UC (bladder, renal) cancer. Nutritional and psychological education will be provided at regular intervals and the patient parameters will be remeasured at the plasma levels. In addition, body mass index monitoring and routine biochemical tests of all patients will be performed during this period. Statistically, Student-t will be used in binary comparisons and ANOVA tests will be used in triple comparisons.

If our hypothesis is realized, new cachectic factors have been identified, specific markers have been identified for GIS and UC cancers, the effect of psychological and nutritional education on cachexia will be answered within the scope of this project.

In line with the data to be obtained from this project in terms of career planning, atrophy and cachexia can be slowed down by injection of irisin and atropine to animals with cachectic cancer models in future projects and it can be planned to treat cancer types with high attenuation. In cancer patients, whose name creates fear in the society, affects people both physiologically and psychologically, and leads people to the bottom in the weakening coexistence, investigators aim to prevent psychological improvement as well as to prevent nutritional deficiencies and to increase the life expectancy in a lifetime. This multicenter and interdisciplinary project that investigators envisaged will enable us to show that investigators are ready for international projects.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

1. st group of cancer patients given psychological support
2. nd group of cancer patients given nutrition education
3. rd group of cancer patients who received psychological support and nutrition education
4. th group of cancer patients who will not receive any support
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants in the study will not know which group.

Study Groups

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psychological support and nutritional education

psychological support and nutritional education will be given to the experimental group.

Group Type OTHER

psychological support and nutritional education

Intervention Type OTHER

psychological support and nutritional education will be given to the patients in the experimental group.

no intervation

No intervention will be applied to the control group

Group Type OTHER

no intervation

Intervention Type OTHER

No intervention will be applied to the control group

psychological support

Psychological support will be given to the experimental group.

Group Type OTHER

psychological support

Intervention Type OTHER

psychological support will be given to the patients in the experimental group.

nutritional education

Nutrition education will be given to the experimental group.

Group Type OTHER

nutritional education

Intervention Type OTHER

nutritional education will be given to the patients in the experimental group.

Interventions

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psychological support

psychological support will be given to the patients in the experimental group.

Intervention Type OTHER

nutritional education

nutritional education will be given to the patients in the experimental group.

Intervention Type OTHER

psychological support and nutritional education

psychological support and nutritional education will be given to the patients in the experimental group.

Intervention Type OTHER

no intervation

No intervention will be applied to the control group

Intervention Type OTHER

Other Intervention Names

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experimental group. experimental group. experimental group. control group

Eligibility Criteria

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Inclusion Criteria

Must be older than 18 years of age, Clinical diagnosis of pancreatic, colon, renal, bladder cancer, and not having any other chronic disease.

Exclusion Criteria

* major gastrointestinal disease, chronic renal failure, uncontrolled diabetes, and HIV
* body mass index\>30kg/m2,
* patients receiving drug therapy that modulates metabolism or weight deeply,
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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diler us altay

assoc.prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ORDU551

Identifier Type: -

Identifier Source: org_study_id

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