Randomized clinical trial of early versus routine oral nutritional supplementation during concurrent CRT for nasopharyngeal carcinoma

Oral nutritional supplementation (ONS) is widely used during concurrent chemoradiotherapy (CCRT) for nasopharyngeal carcinoma (NPC), but its optimal timing is not clear. A randomized clinical trial at six centers in China evaluated efficacy and explored cost utility of early ONS in patients with NPC undergoing CCRT. Eligible patients were aged 18 to 70 years with newly diagnosed stage II to IVA NPC, a Patient-Generated Subjective Global Assessment (PG-SGA) score of 0 to 8, and planned CCRT. Participants were randomized 1:1 to early ONS at CCRT start or routine ONS after prespecified nutritional decline. The primary endpoint was incidence of more than 5% weight loss from baseline to CCRT completion. The modified ITT population included 216 patients (mean age 46.6 years; SD 11.2; 77.8% male), with 107 receiving early ONS and 109 receiving routine ONS. More than 5% weight loss occurred in 65.4% of participants in the early ONS group and 80.7% of participants in the routine ONS group (RR 0.81; p=0.01). Grade 3 or higher radiation-induced oral mucositis (RIOM) occurred in 14.0% of participants in the early ONS group and 26.6% of participants in the routine ONS group (RR 0.53; 95% CI 0.30-0.93). From the perspective of the Chinese health care system, early ONS was associated with lower costs and more QALYs compared with routine ONS. The authors conclude that these findings suggest that early ONS reduces clinically meaningful weight loss during CCRT; exploratory analyses suggested potential benefits for severe RIOM and a potentially favorable short-term economic profile.