Clinical trial NCT05262192: Nutrition Education and Quality of Life in Cancer Cachexia
Official title: Assessment of Irisin Level in Cancer Anorexia Cachexia Syndrome and Improving Quality of Life With Nutrition Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Cachexia
Keywords: Cancer Anorexia Cachexia Syndrome
irisin
cachectic factors
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nutrition education will be given to the experimental group. No intervention will be applied to the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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. ..

Primary outcomes:
measure: SF-36 Quality of Life Scale
timeFrame: 12 weeks
measure: Determination of biochemical parameters 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: Alanine transaminase measurument in plasma samples
timeFrame: 12 weeks
measure: Aspartate transaminase measurument in plasma samples
timeFrame: 12 weeks
measure: Urea measurument in plasma samples
timeFrame: 12 weeks
measure: Creatinine measurument in plasma samples
timeFrame: 12 WEEKS
measure: Prealbumin measurument in plasma samples
timeFrame: 12 weeks
measure: Transferrin measurument in plasma samples
timeFrame: 12 weeks
measure: albumin measurument in plasma samples
timeFrame: 12 weeks
measure: fibrinogen measurument in plasma samples
timeFrame: 12 WEEKS
measure: Ceruloplasmin measurement in plasma samples
timeFrame: 12 weeks
measure: Alpha-1 antitrypsin measurement 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Diler US ALTAY, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: