Monitoring the Nutritional Status of Head and Neck Cancer Patients During Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- PG-SGA Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PG-SGA Score
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
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
Body Composition - BIA
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
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
Quality of Life - EORTC QLQ-H&N35
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
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)
Handgrip Strength
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
Muscle strength will be measured using a handgrip dynamometer; the average of three trials will be used. Unit of Measure: kg
Dietary Intake - 24-Hour Food Recall
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
Daily food intake will be recorded using the 24-hour recall method and analyzed using nutrition software to evaluate energy and nutrient adequacy.
Mid-Upper Arm Circumference (MUAC)
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
Measured using a flexible tape at the midpoint between the shoulder and elbow. Unit of Measure: cm
Body Mass Index (BMI)
时间窗: Weekly during radiotherapy and at follow-up visit (1 month after treatment)
Calculated from measured weight and height using the formula kg/m². Unit of Measure: kg/m²
次要结局
- 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))
- Prealbumin(Weekly during radiotherapy and at follow-up visit (1 month after treatment))
- Total Protein(Weekly during radiotherapy and at follow-up visit (1 month after treatment))
- C-Reactive Protein (CRP)(Weekly during radiotherapy and at follow-up visit (1 month after treatment))
- Treatment-Related Side Effects - CTCAE v5.0(Weekly during radiotherapy and at follow-up visit (1 month after treatment))
- Physical Activity - IPAQ-SF(Weekly during radiotherapy and at follow-up visit (1 month after treatment))
研究者
Zehra Margot Celik
Principal Investigator
Marmara University