Nutritional Status of Head and Neck Cancer Patients

Marmara University

Status: Enrolling

Conditions: Nutritional Status; Radiotherapy; Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07068711

24062025-68

Details and patient eligibility

About

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.

Full description

This research focuses on evaluating the nutritional status of patients with head and neck cancer who are undergoing radiotherapy at Marmara University Pendik Research and Training Hospital, Radiation Oncology Clinic. Head and neck cancers often impair essential functions such as chewing, swallowing, and taste due to both tumor location and treatment side effects. These complications can severely reduce oral intake, leading to weight loss and malnutrition-factors known to negatively affect treatment outcomes and quality of life.

The study is planned to take place between July 1, 2025, and December 31, 2025, with the possibility of extending data collection until March 2026 if necessary. A total of 57 patients aged 18 years and older, who meet specific inclusion criteria and voluntarily consent to participate, will be enrolled.

Throughout the radiotherapy process and one month following its completion, participants' nutritional status and related health parameters will be systematically monitored. The following data collection methods will be used:

Body composition will be assessed weekly using bioelectrical impedance analysis (BIA), a non-invasive method that provides data on body fat, lean body mass, and water content.

Anthropometric measurements such as weight, height, waist and hip circumference, and mid-upper arm circumference will be performed.

Handgrip strength, a widely used indicator of muscle function and nutritional risk, will be measured weekly with a standardized dynamometer.

Dietary intake will be evaluated using 24-hour food recall interviews.

Nutritional risk screening tools, including the Patient-Generated Subjective Global Assessment (PG-SGA) and NUTRISCORE, will be administered to assess malnutrition risk.

Blood biochemical markers, including albumin, prealbumin, total protein, and C-reactive protein (CRP), will be recorded from patient files to assess nutritional and inflammatory status.

Quality of life will be measured using the validated EORTC QLQ-H&N35 questionnaire, specifically designed for head and neck cancer patients.

Treatment-related side effects (e.g., mucositis, dry mouth, swallowing difficulty) will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).

All data will be collected through direct face-to-face interviews, clinical assessments, and medical record reviews. No experimental intervention will be administered; patients will receive their standard medical treatment as prescribed.

The primary goal of this study is to identify how radiotherapy affects the nutritional status of head and neck cancer patients, and how these changes relate to quality of life and treatment tolerance. Findings from this study will support the development of targeted nutritional strategies to improve patient outcomes and well-being during cancer treatment.

Enrollment: 57 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

57 participants in 1 patient group

Head and Neck Cancer Patients

Description:

Patients over 18 years of age receiving radiotherapy