Nutritional Status of Head and Neck Cancer Patients

NCT07068711 | Recruiting

• 1 other identifier: 24062025-68
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to monitor the nutritional status of patients with head and neck cancer undergoing radiotherapy treatment. Throughout the treatment process, patients' body composition, handgrip strength, food intake, quality of life, and treatment-related side effects will be regularly assessed. Measurements will include physical parameters like body weight, height, and waist circumference, as well as blood test results and nutrition-related questionnaires. By closely tracking these changes, the study seeks to identify early signs of nutritional deterioration and support timely interventions. The goal is to better understand nutrition-related challenges during treatment and ultimately improve patients' quality of life.

Conditions

Head and Neck Cancer; Radiotherapy; Nutritional Status

Keywords

head and neck cancer; radiotherapy; nutritional status; quality of life; adverse events

Outcome Measures

Primary Outcomes (7)

• PG-SGA Score

  Nutritional status will be evaluated using the Patient-Generated Subjective Global Assessment (PG-SGA), a validated tool for assessing nutritional risk in cancer patients. The total score ranges from 0 to ≥35, with higher scores indicating worse nutritional status and greater need for nutritional intervention. A PG-SGA score \>9 indicates a critical need for intervention. Unit of Measure: PG-SGA total score

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Body Composition - BIA

  Body composition will be assessed using bioelectrical impedance analysis (BIA), which provides the following measurements: body weight, body fat mass, fat-free mass, total body water, intracellular water, and extracellular water. All measurements will be reported in kilograms (kg). Note: Body Mass Index (BMI) will be calculated and reported separately as a distinct outcome measure in kg/m². Unit of Measure: kg

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Quality of Life - EORTC QLQ-H&N35

  Patient-reported quality of life will be assessed using the EORTC QLQ-H\&N35 questionnaire, a validated instrument developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with head and neck cancer. Scores range from 0 to 100. Higher scores indicate a higher level of symptoms or problems, and therefore represent worse quality of life for symptom-related scales (e.g., pain, swallowing, speech). Unit of Measure: QLQ-H\&N35 scale score (0-100)

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Handgrip Strength

  Muscle strength will be measured using a handgrip dynamometer; the average of three trials will be used. Unit of Measure: kg

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Dietary Intake - 24-Hour Food Recall

  Daily food intake will be recorded using the 24-hour recall method and analyzed using nutrition software to evaluate energy and nutrient adequacy.

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Mid-Upper Arm Circumference (MUAC)

  Measured using a flexible tape at the midpoint between the shoulder and elbow. Unit of Measure: cm

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Body Mass Index (BMI)

  Calculated from measured weight and height using the formula kg/m². Unit of Measure: kg/m²

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

Secondary Outcomes (10)

• Malnutrition Risk - NUTRISCORE

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Waist Circumference

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Hip Circumference

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Waist-to-Hip Ratio (WHR)

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

• Serum Albumin

  Weekly during radiotherapy and at follow-up visit (1 month after treatment)

Study Arms (1)

Head and Neck Cancer Patients

Patients over 18 years of age receiving radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer patients from a University Hospital in Istanbul / Türkiye

You may qualify if:

• Patients aged 18 years and older
• Diagnosed with head and neck cancer
• Receiving radiotherapy at Marmara University Pendik Training and Research Hospital, Radiation Oncology Clinic
• Willing to participate and able to provide written informed consent
• Able to communicate and cooperate during assessments

You may not qualify if:

• Patients for whom BIA measurement is not possible (e.g., caffeine intake within the last 4 hours, alcohol use in the last 24 hours, intense physical activity in the last 24-48 hours, menstruation, presence of pacemaker or metal implants)
• Patients with communication barriers or cognitive impairments
• Amputees or individuals with severe upper extremity deformities
• Patients with neuromuscular disorders, hemiplegia, rheumatoid arthritis, or moderate/severe neurological or cognitive impairment
• Patients receiving parenteral nutrition

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital Radiation Oncology Clinic

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Beste M Atasoy, Prof. Dr.

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Zehra M Çelik, PhD

CONTACT

+905327070972; zcelik@marmara.edu.tr

Zehra Ermiş, Bachelor

CONTACT

+905344437453; dlykurtoglu25@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

TU (1)