Non-Inferiority of a Ready-to-Drink Enteral Formula on Nutritional Status in Patients with Head and Neck Cancer: A Randomized Controlled Trial.

Background/

Objectives

Malnutrition affects 20-71% of patients with head and neck cancer (HNC), owing to tumor location, treatment-induced toxicities, and systemic inflammation. Enteral nutrition is preferred when oral intake is inadequate, yet standard powdered formulas require labor-intensive reconstitution and carry a contamination risk. PSU Blen, a ready-to-drink chicken-protein-based polymeric formula, was developed to address these limitations.

Methods

In this single-center study, thirty clinically stable patients with HNC on tube feeding were randomized 1:1 to PSU Blen or a commercial powdered polymeric formula (Blendera) for 4 weeks. The primary outcome was change in Patient-Generated Subjective Global Assessment (PG-SGA) score from baseline to week 4, analyzed under a prespecified non-inferiority framework (margin δ = 2 points, selected as a clinically acceptable upper bound based on published PG-SGA data). Secondary outcomes were handgrip strength, body weight, body mass index, serum albumin, hemoglobin, and platelet count.

Results

The mean change in PG-SGA score was -1.13 (SD 0.92) and -0.87 (SD 1.36) in the PSU Blen and Blendera groups; the between-group difference was -0.27 points (two-sided 90% CI: -0.99 to +0.45), with the upper bound below the non-inferiority margin. Sensitivity analyses yielded consistent results. No significant between-group differences were observed for secondary outcomes, and both formulas were well tolerated, with no gastrointestinal intolerance or serious adverse events.

Conclusions

PSU Blen demonstrated non-inferior nutritional outcomes based on the PG-SGA endpoint over 4 weeks, with comparable tolerability. Longer-term and multicenter studies are warranted to further evaluate its clinical utility and practical advantages in routine enteral nutrition practice.