Effects of Nutritional Interventions on Quality of Life in Patients with Nasopharyngeal Carcinoma Undergoing Radiation Therapy Based on Dynamic Nutritional Risk Screening and Assessment: An Open-Label Single-Center Randomized Phase 3 Trial.

Abstract

Malnutrition is common among patients with nasopharyngeal carcinoma (NPC) undergoing radiation therapy and is associated with diminished quality of life (QoL). However, the impact of individualized nutritional interventions (NIs) on QoL improvement in this population remains unclear. This study aimed to evaluate the effectiveness of NIs patients with NPC, guided by dynamic nutritional risk screening, in improving QoL and reducing malnutrition during radiation therapy. Patients with histologically confirmed NPC scheduled for intensity modulated radiation therapy (total dose 69.96 Gy in 33 fractions) underwent 1:1 randomization into the NIs or standard of care (SoC) groups. Patients in the NIs group received personalized nutritional support based on weekly assessments using the Patient-Generated Subjective Global Assessment (PG-SGA), whereas those in the SoC group received routine dietary care. NIs commenced during the preradiation therapy clinical assessment and were maintained until radiation therapy completion. The primary endpoint was global health status score at the end of radiation therapy. Secondary outcomes included the Nutritional Risk Screening 2002, PG-SGA scores, and changes in weight and body mass index (BMI). Of the 268 patients randomized, 249 were included in the final analysis (124 in the NIs and 125 in the SoC). Both cohorts demonstrated male predominance (NIs: 75.8%; SoC: 73.6%) with identical median ages of 52 years. At the end of radiation therapy, the NIs group demonstrated a significantly higher mean global health status score than the SoC group (mean difference [MD]: 21.0 points; 95% CI: 17.4-24.7; P < .001). The NIs group showed significantly less weight loss (MD: 1.5 kg; 95% CI: 0.6-2.3; P = .001) and lower BMI decline (MD: 0.6 kg/m²). Clinically relevant weight loss (≥5%) occurred in 50% and 68% patients in the NIs and SoC groups, respectively. The difference in PG-SGA scores was 3.1 (P < .001). Generalized estimating equation longitudinal analysis confirmed a significantly more gradual decline in weight, BMI, and PG-SGA scores with NIs than SoC. Individualized NIs significantly improve QoL and nutritional status in patients with NPC undergoing radiation therapy, underscoring the importance of ongoing assessment-guided individualized nutritional support.