Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Both domestic and international guidelines advocate early nutritional intervention for HNC patients at risk of malnutrition; however, specific recommendations on the type of nutritional treatment are lacking. Immunonutrition has shown promise in regulating the immune microenvironment, enhancing immune response, and reducing radiotherapy side effects compared to conventional nutritional interventions. However, there is a lack of studies focusing on immunonutritional therapy during the radiotherapy process for HNC in China. Therefore, this study aims to investigate the effects of immunonutrition on nutritional status, immune function, and quality of life (QoL) in head and neck cancer (HNC) patients undergoing radiotherapy.
This prospective interventional study enrolled 48 head and neck cancer (HNC) patients scheduled to undergo radiotherapy (with or without concurrent chemotherapy). All participants received an immunonutrition formula supplemented with arginine, ω-3 fatty acids, and nucleotides. Throughout the radiotherapy course, certified dietitians and oncology nurses provided standardized nutritional guidance based on a five-step nutritional management protocol. Primary outcomes included:Radiotherapy-related adverse events (e.g., mucositis, dysphagia) assessed at four time points during radiotherapy (weeks 1, 3, 5, and 7) using CTCAE v4.0 criteria;Longitudinal changes in nutritional status (serum albumin, BMI), immune-related biomarkers , and quality of life were assessed at baseline, mid-radiotherapy (week 4), and post-treatment (week 7).
Patients must be histologically or cytologically confirmed to have head and neck cancer (HNC).
Scheduled for radiotherapy with or without concurrent chemotherapy.
Willingness to sign informed consent voluntarily.
Aged between 18 and 75 years old.
Prior history of radiation therapy or biological therapy targeting the head and neck region.
History of other malignant tumors in the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
Severe systemic diseases, such as uncontrolled diabetes mellitus, severe cardiovascular disease, or chronic renal failure.
Pregnancy or lactation.
Single group
IMPACT
Dietary supplementimmune enhanced formula enriched in arginine, n-3 PUFA and nucleotide
Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)
The grades of oral mucositis were measured and recorded by our professional nutritionists at four time periods during radiotherapy. The classification standard of oral mucositis was based on CTCAE v4.0 (Grade 0: asymptomatic; Grade I: Erythema appears on the oral mucosa, accompanied by pain, but it does not affect eating; Grade II: Erythema and ulcers appear on the oral mucosa, and solid food can be consumed; Grade III: Severe erythema and ulcers appear on the oral mucosa, and solid food cannot be consumed; Grade IV: Ulcers have fused into patches, with necrosis, and the patient is unable to eat)
Change in body weight (kg) from baseline
Measured in kilograms using a calibrated scale, with participants in light clothing and fasting overnight
Change in Body Mass Index (BMI, kg/m²) from baseline
Calculated from measured weight and height (BMI = weight\[kg\] / height\[m\]²)
Change in serum albumin concentration (g/dL) from baseline
Measured from venous blood samples using standardized clinical laboratory assays
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