Nutritional Status of Head and Neck Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Head and neck cancer patients from a University Hospital in Istanbul / Türkiye
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
57 Participants
are grouped into 1 trial groupGroup A: Head and Neck Cancer Patients
Trial outcomes
Primary outcomes
1
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
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)2
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
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)3
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)
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)4
Handgrip Strength
Muscle strength will be measured using a handgrip dynamometer; the average of three trials will be used. Unit of Measure: kg
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)Secondary outcomes
1
Malnutrition Risk - NUTRISCORE
Malnutrition risk will be assessed using the NUTRISCORE screening tool, which evaluates nutritional status in oncology patients based on multiple risk factors. The total score ranges from 0 to 9, with higher scores indicating greater risk of malnutrition. A score ≥5 indicates a significant risk of malnutrition and the need for nutritional intervention. Unit of Measure: NUTRISCORE score
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)2
Waist Circumference
Measured at the midpoint between the lower margin of the last rib and the iliac crest. Unit of Measure: cm
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)3
Hip Circumference
Hip circumference will be measured at the widest part of the hips using a flexible, non-stretchable measuring tape while the participant is standing upright. Unit of Measure: cm
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)4
Waist-to-Hip Ratio (WHR)
Calculated by dividing waist circumference by hip circumference.
Time frame
Weekly during radiotherapy and at follow-up visit (1 month after treatment)Sponsors and contacts
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Source ClinicalTrials.gov