Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Psychological support will be given to the experimental group.

Nutrition education will be given to the experimental group.

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

No intervention will be applied to the control group

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

psychological support

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

nutritional education

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

psychological support and nutritional education

no intervation

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.

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.

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

Participants in the study will not know which group.

Slimming Myokines, Cancers,Nutritional and Psychology Support

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

The scale is applied to patients with physical illness and those applying to primary health care services. The scale consists of 14 questions in total. Seven of them (odd numbers) measure anxiety and the other seven (even numbers) measure depression. Scoring; Each item is scored differently. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and the scoring is 3,2,1, 0. On the other hand, the 2nd, 4th, 7th, 9th, 12th, and 14th items are scored as 0,1,2,3. The total scores of the subscales are obtained by summing these item scores. While collecting the 1st, 3rd, 5th, 7th, 9th, 11th, and 13th items for the anxiety subscale; for depression subscale; The scores of the 2nd, 4th, 6th, 8th, 10th, 12th, and 14th items are added up. Interpretation; As a result of the study conducted in Turkey, the cut-off score for the anxiety subscale was found to be 10/11 and 7/8 for the depression subscale. Accordingly, those above these scores are considered at risk.

Turkish validity and reliability were performed in 2019 in cancer patients. The scale is a 10-point Likert-type scale that measures holistic well-being with 30 items and 7 dimensions and is graded from completely disagree (1) to completely agree (10). Sub-dimensions of the scale: Non-attachment (18, 12, 24, 5, 25), distressing emotion (6, 21, 1, 28, 3), distressing perception (17, 8, 7, 29, 30), spiritual deterioration (20, 26, 2, 4), cognitive awareness (22, 13, 19, 11), general mood (15, 10, 14, 23), spiritual self-care (9, 16, 27). The 4th item in the scale is reverse coded. There is no cut-off point in the scale. The highest score that can be obtained from the scale is 300, and the lowest score is 30. Cronbach's alpha value ranged from 0.670 to 0.892.

After reaching a sufficient number of patients, slimming myokines, cachectic factors, cytokines protein levels will be measured by the commercial kits ELISA (Enzyme-Linked Immunosorbent Assay) method.ELISA technique is the gold standard for quantitation of soluble proteins and provides rapid and consistent results that are easy to analyze.

Hemoglobin (Hgb( g/dL); grams of hemoglobin per deciliter.

Especially body mass indexes of all patients weight and height will be combined to report BMI in kg/m\^2 will be measured again at the beginning of the study and after the nutrition and psychological training.

C-reactive protein (CRP(mg/L) milligrams of CRP per liter. It is possible to say that high CRP levels indicate an acute inflammatory reaction or an infection in the body, and a decrease in CRP levels indicates that the inflammatory reaction or infection has started to decrease

Aspartate transaminase (AST(U/L) units of AST per liter.Plasma AST (aspartate transaminase) level is commonly measured clinically as a biomarker for liver health. The test is part of blood panels.

Alanine transaminase (ALT (U/L) units of ALT per liter. Plasma ALT level is commonly measured clinically as a biomarker for liver health. The test is part of blood panels.

Urea (mg/dL)milligrams of urea per deciliter. Blood urea nitrogen (BUN) is a medical test that measures the amount of urea nitrogen found in the blood. The liver produces urea in the urea cycle as a waste product of the digestion of protein. Normal human adult blood should contain 6 to 20 mg/dL (2.1 to 7.1 mmol/L) of urea nitrogen.

Total protein (g/dL) grams of total protein per deciliter. A total protein test is requested if you have a complaint about your nutritional status, such as weight loss. In the presence of symptoms suggestive of liver or kidney diseases or in the presence of symptoms such as fluid pooling (edema) in the tissues, it may be requested together with other tests.

Creatinine(mg/dL) milligrams of creatinine per deciliter. Normal creatinine values average 0.6-1.3 mg/dL. If this value is above 2.0, renal failure is considered. However, in some cases, it has been observed that the creatinine value increases due to the rapid muscle metabolism in athletes who do heavy sports.

Cancer antigen 15-3 (CA15-3) (U/mL) units of CA 15-3 per milliliter. Cancer antigen 15-3 is a protein made by a variety of cells, particularly breast cancer cells. The protein moves into the blood, where it can be measured.CA15-3 levels are higher than normal in most women with breast cancer that has spread to other parts of the body (called metastatic breast cancer). Not all types of breast cancer will cause CA 15-3 levels to rise, as some types of cancer cells don't over-produce the antigen.

Cancer antigen 19-9 (U/mL) units of CA 19-9 per milliliter. This test measures the amount of a protein called CA 19-9 (cancer antigen 19-9) in the blood. CA 19-9 is a type of tumor marker. Tumor markers are substances made by cancer cells or by normal cells in response to cancer in the body.

carcinoembryonic antigen (CEA)(ng/mL) nanograms of carcinoembryonic antigen per milliliter. Carcinoembryonic antigen (CEA) is a protein normally found in very low levels in the blood of adults. The CEA blood level may be increased in certain types of cancer and non-cancerous (benign) conditions. A CEA test is most commonly used for colorectal cancer.

All tissue samples will be studied simultaneously by taking sections from the FFPE block.

In our study, Invitrogen brand Pure Link to FFPE Total RNA isolation kit will be used. The operating procedure in the kit protocol will be followed. The spectrophotometric method will be used to determine the amount and quality of RNAs obtained before cDNA extraction.

1 μl of the obtained RNAs will be loaded into the BioSpec-Nano (Shimadzu, Kyoto, Japan) device for contamination and concentration determination. The 260/280 absorbance ratio should ideally be around 2 for RNA samples. Samples that are too far from this value mean that there is contamination and RNA isolation will be repeated. RNA concentrations will be diluted to 100 μg/ml so that the initial RNA amounts of all samples are equal before cDNA translation.

ipsogen RT Kit (cDNA synthesis kit) will be used to convert the obtained Total RNA to cDNA. The operating procedure in the kit's protocol will be followed. The mixtures created will be exposed to 25°C for 10 minutes, 50°C for 60 minutes, 85°C for 5 minutes, and 4°C for 5 minutes within the reverse transcription (RT) program. cDNAs will be stored at -20°C until Real-Time PCR is performed. If necessary, it will be stored at -80oC to prolong the lifetime of cDNAs.

The measurement of the slimming myokines, cachectic factors, cytokine parameters at the gene levels in the tissues is planned to be measured by the GeneaQ device will be used. The operating procedure in the kit's protocol will be followed.

T.C. ORDU ÜNİVERSİTESİ

assoc.prof

Behaviors and Mental Disorders

Syndrome

Anorexia

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Quality of Life

No intervention will be applied to the control group.

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

nutrition education

Diler US ALTAY, Assoc. Prof.

With the project the investigators propose, the investigators aim to find answers to the following questions: Are some cachectic factors and cytokines associated with plasma level irisin in patients with advanced stage cancer diagnosed with CACS? Could irisin be a new cachectic factor for patients with CACS? Can providing nutritional education to these patients slow cachexia and can a quality survival be achieved in line with the data obtained from the assessment of quality of life? and the experimental approaches to find answers to these questions make this project unique.

Cancer is the uncontrolled growth of a group of cells in the body. Side effects related to cancer and treatments are one of the most difficult issues for patients and physicians. Cachexia is the second cause of cancer-related deaths after sepsis. Cachexia is a condition that progresses with weight loss in cancer patients and cannot be reversed with normal nutrition. In recent years, it has been found that cancer cachexia is associated with anorexia and has been named as cancer anorexia cachexia syndrome (CACS). Along with involuntary weight loss, appetite loss is observed in CACS patients and this decreases the quality of life. CACS is most common in people with advanced disease and the occurrence of the syndrome depends on the types of cancer. Weight loss is seen before starting treatment in 50-85% of gastrointestinal, pancreatic, lung and colorectal cancers. CACS is held responsible for 20% of cancer-related deaths. Despite these conditions, it is still considered unimportant and often incurable.

The occurrence of CACS depends on many factors. It has not been fully clarified yet which biochemical mechanisms arise. In this process, cachectic factors released from tumor cells and causing muscle and fat atrophy are proteolysis inducing factor (PIF), Zinc-α-2 Glycoprotein (ZAG) and the proinflammatory cytokines (tumor necrosis factor-α (TNF-α), Interleukin-1 (IL-1), interleukin-6 (IL-6)), which are over-synthesized by the body, importance is known. However, the search for new and more precise agents to cause cachexia is still ongoing. Irisin, which causes weight loss, a newly discovered adipomyokine known to have antiinflammatory, antidiabetic, and antiobesity effects.

With the project the investigators propose, the investigators aim to find answers to the following questions: Are some cachectic factors and cytokines associated with plasma level irisin in patients with advanced stage cancer diagnosed with CACS? Could irisin be a new cachectic factor for patients with CACS? Can providing nutritional education to these patients slow cachexia and can a quality survival be achieved in line with the data obtained from the assessment of quality of life? and the experimental approaches to find answers to these questions make this project unique.

Within the scope of this project, firstly, irisin will be measured in plasma samples taken from 80 patients diagnosed with advanced cancer, who have been diagnosed with CACS together with some cachectic factors and cytokines. Randomly selected nutrition education to be given and not given patients, measurements of all determined parameters at plasma levels will be made again at specified time intervals (starting 12th week and 24th week). In addition, all patients during this process body weight, oral intake status, amount of food consumed in the last 24 hours, presence of nausea / vomiting, chewing and swallowing functions, body mass index (BMI-kg / m2), lean mass index (BMI-kg / m2), weight loss and comprehension performance status (CPS), routine biochemical tests and quality of life assessment scales will be done

If our hypothesis is realized, possible biomarker specific to CACS has been identified,nutritional education will be answered for the first time within the scope of this project to slow down CACS and provide better quality of survival during the disease. In line with the data obtained from this project, in future projects, cachectic cancer model can be created for animals, irisin injection can slow down atrophy and cachexia, and thus, quality survival can be achieved in cancer types with high attenuation. With this work, the investigatorscreate fear in the society,affect people negatively,dragging people to the bottom with the attenuation,the investigators aim to improve the life expectancy of cancer patients, that is, to increase the quality of survival.

Nutrition education will be given to the experimental group. No intervention will be applied to the control group.

Nutrition Education and Quality of Life in Cancer Cachexia

Assessment of Irisin Level in Cancer Anorexia Cachexia Syndrome and Improving Quality of Life With Nutrition Education

The SF-36 Short Form was developed and made available by Rand Corporation to assess the quality of life. It was translated into Turkish in our country and its validity and reliability study was carried out by Koçyiğit et al. In addition to being short and easy to apply, the scale has a wide range of uses. SF-36 short form is frequently used to determine the quality of life in cancer patients. The SF-36 quality of life scale consists of 36 questions and eight sub-dimensions. SF-36 has 8 sub-dimensions as general health perception, physical function, physical role, pain, vitality, social function, mental role, and mental function, and 2 summary areas as mental health and physical health.

The summary scores obtained were expressed as a continuous variable ranging from zero to one hundred. Zero indicates ill health, 100 indicates well-being. The purpose of obtaining summary scores is to facilitate interpretation and comparisons

After reaching a sufficient number of patients, slimming myokines, cachectic factors, and cytokines will be measured by the commercial kits ELISA (Enzyme-Linked Immunosorbent Assay) method. ELISA technique is the gold standard for quantitation of soluble proteins and provides rapid and consistent results that are easy to analyze.

C-reactive protein (CRP(mg/L) miligrams of CRP per liter.It is possible to say that high CRP levels indicate an acute inflammatory reaction or an infection in the body, and a decrease in CRP levels indicates that the inflammatory reaction or infection has started to decrease.

Prealbumin(mg/dL); milligrams of prealbumin per deciliter. It is used to evaluate nutritional status. Measurement of blood prealbumin level is especially important in premature infants or people with suspected malnutrition.

Transferrin(mg/dL); milligrams of transferrin per deciliter. Transferrins are glycoproteins found in vertebrates that bind to and consequently mediate the transport of iron (Fe) through blood plasma. They are produced in the liver and contain binding sites for two Fe3+ ions. The transferrin test is a laboratory test that provides information about the saturation of transferrin with iron. The transferrin test is usually ordered when iron deficiency is suspected.

Albumin (g/dL)grams of albumin per deciliter. It is the most important protein in the blood plasma that regulates the oncotic pressure that allows large protein molecules to pass through narrow areas such as capillaries.

fibrinogen (mg/dL) milligrams of fibrinogen per deciliter. Fibrinogen (factor I) is a glycoprotein complex, produced in the liver, that circulates in the blood of all vertebrates.During tissue and vascular injury, it is converted enzymatically by thrombin to fibrin and then to a fibrin-based blood clot.

Ceruloplasmin (mg/dL) milligrams of ceruloplasmin per deciliter. Ceruloplasmin(or caeruloplasmin) is a ferroxidase enzyme that in humans is encoded by the CP gene. Ceruloplasmin is the major copper-carrying protein in the blood, and in addition, plays a role in iron metabolism.

Alpha-1 antitrypsin (mg/dL) ; milligrams of alpha-1 antitrypsin per deciliter. Alpha-1 antitrypsin deficiency (A1AD or AATD) is a genetic disorder that may result in lung disease or liver disease. The onset of lung problems is typically between 20 and 50 years of age.\[This may result in shortness of breath, wheezing, or an increased risk of lung infections. Complications may include chronic obstructive pulmonary disease (COPD), cirrhosis, neonatal jaundice, or panniculitis.

Cancer antigen 15-3 (CA15-3) (U/mL) units of CA 15-3 per mililiter. Cancer antigen 15-3 is a protein made by a variety of cells, particularly breast cancer cells. The protein moves into the blood, where it can be measured.CA15-3 levels are higher than normal in most women with breast cancer that has spread to other parts of the body (called metastatic breast cancer). Not all types of breast cancer will cause CA 15-3 levels to rise, as some types of cancer cells don't over-produce the antigen.

carcinoembryonic antigen (CEA)(ng/mL) nanograms of carcinoembryonic antigen per mililiter. Carcinoembryonic antigen (CEA) is a protein normally found in very low levels in the blood of adults. The CEA blood level may be increased in certain types of cancer and non-cancerous (benign) conditions. A CEA test is most commonly used for colorectal cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Slimming Myokines, Cancers,Nutritional and Psychology Support	NCT05278078	Cancer	psychological s... nutritional edu... psychological s... no intervation	50 Years - 80 Years	T.C. ORDU ÜNİVERSİTESİ
Nutrition Education and Quality of Life in Cancer Cachexia	NCT05262192	Cancer Cachexia	nutrition educa...	50 Years - 80 Years	T.C. ORDU ÜNİVERSİTESİ
Nutrition Education and Quality of Life in Cancer Cachexia	NCT05262192	Cancer Cachexia	nutrition educa...	50 Years - 80 Years	T.C. ORDU ÜNİVERSİTESİ

Spots Global Cancer Trial Database for irisin

Every month we try and update this database with for irisin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for irisin

Every month we try and update this database with for irisin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for irisin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.