Cancer Cachexia Clinical Trial
Official title:
Assessment of Irisin Level in Cancer Anorexia Cachexia Syndrome and Improving Quality of Life With Nutrition Education
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | January 1, 2023 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - It is planned to be applied to patients with malignancy, being 18 older and including groups of similar age, clinically approved (anorexia-cachexia-clinically approved). Exclusion Criteria: - Patients under the age of 18, having undergone any surgical procedure in the last 4 weeks, received radiotherapy or chemotherapy treatment, received drug therapy that modulates metabolism or weight deeply, patients with different cancer diagnoses, who were followed up and treated in the outpatient clinic before, will not be included in the study group. .. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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T.C. ORDU ÜNIVERSITESI |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SF-36 Quality of Life Scale | 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 Koçyigit 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 |
12 weeks | |
Primary | Determination of biochemical parameters by ELISA method | 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. | 12 weeks | |
Primary | Hemoglobin measurument in plasma samples | Hemoglobin (Hgb( g/dL); grams of hemoglobin per deciliter. | 12 weeks | |
Primary | Body Mass Index Measurument | 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. | 12 weeks | |
Primary | C-reactive protein measurument in plasma samples | 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. | 12 weeks | |
Primary | Alanine transaminase measurument in plasma samples | 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. | 12 weeks | |
Primary | Aspartate transaminase measurument in plasma samples | 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. | 12 weeks | |
Primary | Urea measurument in plasma samples | 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. | 12 weeks | |
Primary | Creatinine measurument in plasma samples | 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. | 12 WEEKS | |
Primary | Prealbumin measurument in plasma samples | 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. | 12 weeks | |
Primary | Transferrin measurument in plasma samples | 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. | 12 weeks | |
Primary | albumin measurument in plasma samples | 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. | 12 weeks | |
Primary | fibrinogen measurument in plasma samples | 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. | 12 WEEKS | |
Primary | Ceruloplasmin measurement in plasma samples | 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. | 12 weeks | |
Primary | Alpha-1 antitrypsin measurement in plasma samples | 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. | 12 weeks | |
Primary | Cancer antigen 15-3 measurement in plasma samples | 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. | 12 weeks | |
Primary | Cancer antigen 19-9 measurement in plasma samples | 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. | 12 weeks | |
Primary | carcinoembryonic antigen (CEA) measurement in plasma samples | 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. | 12 weeks |
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