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Palliative CareNCT06753708

Evaluation of the Nutritional Status of Palliative Care Patients

An observational study of Palliative Care and Tube Feeding, run by Marmara University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the nutritional status of palliative care patients receiving enteral tube feeding. It aims to assess their condition using nutritional screening tools, anthropometric measurements and biochemical data to improve standards of care, patient safety and outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care, Tube Feeding
How many people
132 participants
Where
2 sitesTurkey (Türkiye)
Study dates
25 Nov 2024to 30 Jun 2025
How long will I take part?
10 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Palliative Care patients from a State Hospital in Istanbul / Türkiye

Who may be able to join

  • Being 18 years of age or older
  • Being treated in the Palliative Care Clinic
  • Being fed with one of the tube enteral nutrition methods (only enteral/enteral + oral/enteral)

Who cannot join

  • Having any limb amputation
  • Being hospitalized in the Palliative Care Clinic for less than 3 days
  • Receiving parenteral nutrition support

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Marmara University, Faculty of Health Sciences

    Istanbul, Maltepe, 34854

  • Marmara University

    Istanbul, Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Nutritional Status of Patients Hospitalized in the Palliative Care Unit and Receiving Tube Enteral Nutrition Support

This study evaluates the nutritional status of palliative care patients receiving enteral tube feeding. It aims to assess their condition using nutritional screening tools, anthropometric measurements and biochemical data to improve standards of care, patient safety and outcomes. The study will take place at a state hospital palliative care clinic from November 2024 to March 2025, with a possible extension to June 2025.

Participants will be adults aged 18 years and older undergoing enteral tube feeding. Informed consent will be obtained, and data collection will include in-person interviews, patient questionnaires, food consumption records completed by family members, and biochemical data from medical records. Nutritional information will be analyzed using BeBIS software, and SPSS will be used for statistical analysis.

The study aims to create effective nutrition plans, improve clinical protocols, and improve healthcare outcomes. By addressing gaps in the literature, particularly regarding enteral tube feeding in palliative care, this research will benefit patients, families, healthcare providers, and institutions. Anticipated benefits include improved patient care, reduced complications, shorter hospital stays, and cost savings to the healthcare system.

Read the detailed description

The data obtained from food consumption records will be transferred to the Nutrition Information System (BeBIS) program by the researcher and total energy, macro and micronutrients will be calculated. The data of the individuals participating in the study will be analyzed with SPSS 28.0 (Statistical Package for Social Sciences for Windows) statistical package program.

Institutional, social and economic benefits are also among our goals with this research. The institutional benefits of the research include the evaluation of the nutritional status of patients receiving tube enteral nutrition support, the creation of effective nutrition plans and, when necessary, the provision of improvement recommendations.In addition, by reviewing and updating clinical enteral nutrition protocols, standards of care will be improved and patient safety will increase. This process will encourage more efficient use of resources and increase knowledge and awareness of enteral nutrition among healthcare professionals. It will contribute to the organization's quality improvement efforts, support performance assessments in nutrition and patient care, and improve patient satisfaction and treatment outcomes through effective nutrition support. The societal benefits are to contribute to improving national and international standards for patients receiving tube enteral nutrition support through the development of more effective and targeted nutrition strategies in patient care, efficient use of resources, education on nutrition management for health professionals, families and caregivers, and the development of nutrition management policies based on research findings. The economic benefits of the research will be achieved by improving the nutritional status of patients, reducing complication rates and shortening hospital stays with the effective implementation of tube enteral nutrition management. This will result in a significant reduction in healthcare costs and encourage more efficient use of resources. As a result, reduced material and labor costs will contribute to a more sustainable model of care by reducing the financial burden on the healthcare system.This research aims to evaluate the nutritional status of patients hospitalized in a palliative care ward and receiving tube enteral nutrition support using anthropometric measurements, nutrition screening tools, scales and biochemical findings. Although there are similar studies in the literature, there is no study that specifically examines the status of tube enteral nutrition in palliative care. Existing studies generally focus on enteral nutrition support, deficiencies or malnutrition and quality of life in palliative care. Considering the increase in the elderly population and the number of palliative care hospitalizations, this study aims to make an important contribution to the existing gap in the literature.

The study is planned to include patients over 18 years of age who received inpatient treatment in the Palliative Care Clinic of a Hospital between November 2024 and March 2025 and who received tube enteral nutrition. Approval was obtained from Marmara University Institute of Health Sciences Non-Interventional Clinical Research Ethics Committee for the conduct of this study. A power analysis was performed with the Epi-Info program and the sample size was determined as 132 participants. Considering the losses, 145 patients will be included in the study. If the targeted sample size is not reached, the data collection process is planned to be extended until June 2025. Verbal and written informed consent will be obtained from the patients before data collection. All patients who agree to participate in the study will be interviewed face-to-face and the questionnaire form will be filled out by the researcher. The questionnaire form will include sections on general information about the patient, medical nutrition therapy, anthropometric measurements and biochemical parameters. In addition, each patient's relatives will be asked to fill in the food consumption record form. The nutrition screening tools NRS-2002 and GLIM Criteria will be applied to each patient by the investigator. Filling out the enteral nutrition record form and taking anthropometric measurements will be done by the investigator. Biochemical findings required for the study will be obtained from patient files.

Keywords
Palliative Care, Malnutrition, Nutritional Status, Tube Feeding
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06753708
Study groupRoleWhat they receive
Palliative Care PatientsPatients over 18 years of age who received inpatient treatment in the Palliative Care Clinic of a State Hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malnutrition Status - NRS-2002 Score

    The NRS-2002 tool will be used to evaluate the malnutrition risk of patients. This screening tool, developed by ESPEN in 2002, includes components for nutritional status and disease severity. The total score will be recorded based on the assessment conducted by the researcher.

    Unit of Measure: NRS-2002 score; >3 indicates malnutrition.

    Measured: 7 days after admission to the palliative care unit

  2. Body Mass Index (BMI)

    Calculated from weight (measured or estimated) and height (measured or estimated).

    Unit of Measure: kg/m²

    Measured: 7 days after admission to the palliative care unit

  3. Upper Mid-Arm Circumference

    Measured using a flexible tape measure. Unit of Measure: cm

    Measured: 7 days after admission to the palliative care unit

  4. Skinfold Thickness

    Measured at specified anatomical sites using a Saehan Medical Skinfold Caliper. Unit of Measure: Millimeters (mm)]

    Measured: 7 days after admission to the palliative care unit

  5. Enteral Nutrition Record

    For each patient, enteral nutrition method, type, total daily feeding hours and nutrition infusion rate will be recorded on the form. Interruptions in enteral nutrition due to medical, technical or patient-related reasons, duration of interruption and treatment changes will also be recorded. This information will be obtained from the patients' nutrition files after obtaining the necessary permissions. Target energy and protein levels will be calculated by the investigator for each patient.

    Measured: 7 days after admission to the palliative care unit

  6. Food Consumption Record

    A 24-hour food consumption record will be obtained for patients with oral intake in addition to tube enteral nutrition.

    Measured: 7 days after admission to the palliative care unit

  7. Nutritional Biomarker Index

    A composite nutritional biomarker index will be calculated based on laboratory findings that have been recorded in patients files in the last 7 days. The index will include hemoglobin, hematocrit, albumin, and prealbumin levels, combined using a weighted scoring system to reflect overall nutritional status.

    Unit of Measure: Composite score (unitless)

    Measured: 7 days after admission to the palliative care unit

Secondary outcomes (26)
  1. Phenotypic Criteria - Weight Loss

    Percentage of weight loss will be calculated and recorded. Unit of Measure: Percentage (%)

    Measured: 7 days after admission to the palliative care unit

  2. Phenotypic Criteria - Body Mass Index (BMI)

    BMI will be determined using weight and height measurements. If direct measurements are not feasible due to patient bedridden status, height will be estimated from knee length, and weight will be calculated using upper mid-arm circumference and calf circumference measurements through validated equations.

    Unit of Measure: BMI (kg/m²)

    Measured: 7 days after admission to the palliative care unit

  3. Phenotypic Criteria - Muscle Mass

    Muscle mass will be estimated using a specific validated method (e.g., bioelectrical impedance analysis or anthropometric measurements).

    Unit of Measure: Muscle mass (kg)

    Measured: 7 days after admission to the palliative care unit

  4. Etiologic Criteria - Food Intake

    Daily food intake will be assessed based on a standardized dietary questionnaire or other method. Unit: Kilocalories per day (kcal/day)

    Measured: 7 days after admission to the palliative care unit

  5. Etiologic Criteria - Inflammatory Status

    Inflammatory markers (e.g., CRP, albumin) will be measured using laboratory analysis.

    CRP levels (mg/L), albumin (g/dL)

    Measured: 7 days after admission to the palliative care unit

  6. Knee Length

    Knee length will be measured using a specialized caliper for bedridden patients.

    Unit of Measure: Centimeters (cm)

    Measured: 7 days after admission to the palliative care unit

  7. Calf Circumference

    Calf circumference will be measured using a flexible measuring tape. Unit of Measure: Centimeters (cm)

    Measured: 7 days after admission to the palliative care unit

  8. Height

    Height will be directly measured if feasible, or estimated from knee length using validated equations for bedridden patients.

    Unit of Measure: Meters (m)

    Measured: 7 days after admission to the palliative care unit

  9. Body Weight

    Body weight will be measured directly if feasible, or estimated using upper mid-arm circumference and calf circumference measurements through validated equations.

    Kilograms (kg)

    Measured: 7 days after admission to the palliative care unit

  10. Hemoglobin

    Hemoglobin levels will be recorded from patient files. Unit of Measure: g/dL

    Measured: 7 days after admission to the palliative care unit

  11. Hematocrit

    Hematocrit levels will be recorded from patient files. Unit of Measure: Percentage (%)

    Measured: 7 days after admission to the palliative care unit

  12. Platelet Count

    Platelet Count will be recorded from patient files. Unit of Measure: ×10³/μL

    Measured: 7 days after admission to the palliative care unit

  13. Leukocyte Count

    Leukocyte Count will be recorded from patient files. Unit of Measure: ×10³/μL

    Measured: 7 days after admission to the palliative care unit

  14. Neutrophil Count

    Neutrophil Count will be recorded from patient files. Unit of Measure: ×10³/μL

    Measured: 7 days after admission to the palliative care unit

  15. Lymphocyte Count

    Lymphocyte Count will be recorded from patient files. Unit of Measure: ×10³/μL

    Measured: 7 days after admission to the palliative care unit

  16. Blood Urea Nitrogen (BUN)

    BUN levels will be recorded from patient files. Unit of Measure: mg/dL

    Measured: 7 days after admission to the palliative care unit

  17. Creatinine

    Creatinine levels will be recorded from patient files. Unit of Measure: mg/dL

    Measured: 7 days after admission to the palliative care unit

  18. Magnesium

    Magnesium levels will be recorded from patient files. Unit of Measure: mg/dL

    Measured: 7 days after admission to the palliative care unit

  19. Sodium

    Sodium levels will be recorded from patient files. Unit of Measure: mmol/L

    Measured: 7 days after admission to the palliative care unit

  20. Potassium

    Potassium levels will be recorded from patient files. Unit of Measure: mmol/L

    Measured: 7 days after admission to the palliative care unit

  21. Chlorine

    Chlorine levels will be recorded from patient files. Unit of Measure: mmol/L

    Measured: 7 days after admission to the palliative care unit

  22. Calcium

    Calcium levels will be recorded from patient files. Unit of Measure: mg/dL

    Measured: 7 days after admission to the palliative care unit

  23. CRP

    CRP levels will be recorded from patient files. Unit of Measure: mg/L

    Measured: 7 days after admission to the palliative care unit

  24. Albumin

    Albumin levels will be recorded from patient files. Unit of Measure: g/L

    Measured: 7 days after admission to the palliative care unit

  25. Prealbumin

    Prealbumin levels will be recorded from patient files. Unit of Measure: mg/dL

    Measured: 7 days after admission to the palliative care unit

  26. Glomerular Filtration Rate (GFR)

    GFR levels will be recorded from patient files. Unit of Measure: mL/min/1.73m²

    Measured: 7 days after admission to the palliative care unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start25 Nov 2024
  3. Primary completion30 May 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
132 participants (actual)
Target duration
10 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753708
Sponsor's protocol ID
16.09.2024/85
Status last verified
Dec 2024
First submitted
17 Dec 2024
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

An observational study of Palliative Care and Tube Feeding, run by Marmara University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malnutrition Status - NRS-2002 Score (time frame: 7 days after admission to the palliative care unit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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