Nutritional Counseling with or Without Systematic Use of Oral Nutritional Supplements in Head and Neck Cancer Patients Undergoing Radiotherapy.

10098 Background: The benefit of systematic use of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT) has not still been properly assessed. Methods: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014 - August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with omega-3 enriched ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end. The primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, body composition and quality of life (EORTC-QLQ-C30) over the study time points and anti-cancer treatment tolerance. Results: In patients in whom all the variables could be assessed, counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%CI, 0.5 to 2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR = 0.40 [95%CI, 0.18 to 0.91], P = 0.029). Nine patients reported gastrointestinal intolerance to ONS. Conclusions: In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, weight loss could not be completely prevented, but the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and better anti-cancer treatment tolerance. Clinical trial information: NCT02055833.