Early vs Routine Oral Nutritional Supplementation for Nasopharyngeal Carcinoma

In a multicenter, open-label randomized clinical trial conducted across 6 tertiary hospitals in China from July 2021 to May 2025, investigators evaluated the efficacy and cost utility of early oral nutritional supplementation (ONS) initiated at the start of concurrent chemoradiotherapy (CCRT) compared with routine ONS initiated after prespecified nutritional decline. The trial enrolled patients aged 18 to 70 years with newly diagnosed stage II to IVA nasopharyngeal carcinoma (NPC) and a Patient-Generated Subjective Global Assessment (PG-SGA) score of 0 to 8 scheduled for CCRT. Key exclusion criteria were oral intake below 60% of requirements for 3 or more days, inability or unwillingness to receive concurrent chemotherapy, and inability to receive oral or enteral nutrition.

Of 242 screened patients, 236 were randomized 1:1, and the prespecified modified intention-to-treat (mITT) cohort comprised 216 participants (mean age, 46.62 years; 77.8% male), with 107 allocated to early ONS and 109 to routine ONS. Data analysis occurred from November 2025 to March 2026.

The primary end point was the proportion of patients with greater than 5% weight loss from baseline to CCRT completion. In the mITT population, greater than 5% weight loss occurred in 65.4% (70/107) of participants in the early ONS group compared with 80.7% (88/109) in the routine ONS group (relative risk [RR], 0.81; 95% CI, 0.68-0.96; P = .01). An intention-to-treat analysis across all randomized participants yielded a consistent finding (RR, 0.78; 95% CI, 0.65-0.93).

Secondary outcomes evaluated included PG-SGA scores, grade 3 or higher radiation-induced oral mucositis (RIOM), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and radiotherapy interruptions. Severe RIOM (grade 3 or higher) occurred in 14.0% (15/107) of the early ONS cohort versus 26.6% (29/109) of the routine ONS cohort (RR, 0.53; 95% CI, 0.30-0.93). In exploratory economic analyses, best-case total costs were $9,560.56 with early ONS versus $9,685.23 with routine ONS, yielding quality-adjusted life-years of 0.1144 and 0.1132, respectively. The trial authors concluded that early ONS reduced clinically meaningful weight loss during CCRT, with exploratory findings suggesting reductions in severe RIOM and a potentially favorable short-term economic profile.