Clinical trial NCT05278078: Slimming Myokines, Cancers,Nutritional and Psychology Support
Official title: Investigation of the Slimming Myokines as Biomarkers Potential for Some Gastrointestinal (GIS) and Urinarysystem (US) Cancers and on the Effects of Nutritional and Psychology of Concerned Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: cachexia
irisin
adropine
nutrition
psychology
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Hospital-Anxiety Scale
timeFrame: 12 weeks
measure: Holistic Well-being Scale
timeFrame: 12 Weeks
measure: Determination of slimming myokines, cachectic factors, cytokines protein levels by ELISA method
timeFrame: 12 weeks
measure: Hemoglobin measurument in plasma samples
timeFrame: 12 weeks
measure: Body Mass Index Measurument
timeFrame: 12 weeks
measure: C-reactive protein measurument in plasma samples
timeFrame: 12 weeks
measure: Aspartate transaminase measurument in plasma samples
timeFrame: 12 weeks
measure: Alanine transaminase measurument in plasma samples
timeFrame: 12 weeks
measure: Urea measurument in plasma samples
timeFrame: 12 weeks
measure: total protein measurument in plasma samples
timeFrame: 12 weeks
measure: Creatinine measurument in plasma samples
timeFrame: 12 weeks
measure: Cancer antigen 15-3 measurement in plasma samples
timeFrame: 12 weeks
measure: Cancer antigen 19-9 measurement in plasma samples
timeFrame: 12 weeks
measure: Carcinoembryonic antigen (CEA) measurement in plasma samples
timeFrame: 12 weeks
measure: RNA isolation from Tissue Samples
timeFrame: 12 weeks
measure: cDNA extraction
timeFrame: 12 weeks
measure: Expression analysis of slimming myokines, cachectic factors, cytokines genes by Real-Time PCR
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
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