Head and Neck Cancer Patients Under (Chemo-) Radiotherapy Undergoing NUTritional Intervention: Results From the Prospective Randomized HEADNUT-Trial.

PURPOSE/OBJECTIVE(S) Patients with squamous cell carcinoma of the head and neck (HNSCC) under (chemo-)radiotherapy are at high risk of malnutrition. There are no studies investigating the influence of nutritional status on an altered side effect spectrum and only very few studies examining bioelectric impedance analysis (BIA) and its impact as a prognostic indicator in patients with HNSCC undergoing (chemo-)radiotherapy. Our prospective, randomized, and controlled HEADNUT-trial presented here aimed at preventing increasing malnutrition under radiotherapy or concurrent chemoradiotherapy through specialized and individualized nutritional counseling. Additionally, we investigated whether parameters from BIA were suitable indicators for (threatening) malnutrition and inspected their prognostic effect on (clinical) outcome. MATERIALS/METHODS Between October 2018 and October 2020, 61 patients were randomized into an intervention and control group. Questionnaires (MUST, NRS-2002, and Nutriscore), clinical examinations, laboratory analyses, and BIA were used to assess nutritional status for all patients at the beginning and end of therapy as well as every 2 weeks during therapy. The intervention consisted of an individualized nutritional counseling every 2 weeks during therapy. RESULTS Median baseline BMI for all participants was 23.8 (14.5-37.2) kg/m² and dropped to 22.9 (16.8-33) kg/m² after therapy (P < 0.001). In all patients, median baseline fat-free mass index (FFMI) was 18.1 (14-24.7) kg/m² and decreased to 17.8 (13.4-21.6) kg/m² till the end of therapy (P < 0.001). Compliant patients with a BMI < 22 kg/m² presented with less weight loss in the intervention group compared to the control (P = 0.015, CI: 0.33-2.95). At baseline, MUST was the only screening-test which showed both good sensitivity (86%) and specificity (88%) in detecting malnutrition. Median follow-up was 15 (1-26) months. 2-year overall survival rate was 70% in the control and 79% in the intervention group (log-rank P = 0.79). Pretherapeutic phase angle, posttherapeutic FFMI and albumin level were prognostic indicators for overall survival (log-rank P = 0.002, P = 0.008 and P = 0.016). CONCLUSION Malnutrition negatively impacts patients' outcome under (chemo-)radiotherapy. Baseline phase angle, posttherapeutic FFMI and albumin level are proposed as reliable indicators for overall survival.