Quality of life, HPV-status and phase angle predict survival in head and neck cancer patients under (chemo)radiotherapy undergoing nutritional intervention: Results from the prospective randomized HEADNUT-trial.

PURPOSE: To analyze the impact of quality of life (QoL), nutritional and clinical indicators on overall survival in patients with head and neck squamous cell cancer (HNSCC) undergoing (chemo)radiotherapy. MATERIALS AND METHODS: At the beginning, at the end of (chemo)radiotherapy and during follow-up, QoL was prospectively assessed using the EORTC-QLQ-C30 and -QLQ-H&N35 questionnaires. Data were analyzed in 58 out of 220 screened patients, who were randomized into a control and intervention group. All patients received a nutritional assessment including bioelectrical impedance analysis (BIA), laboratory testing, and a screening for malnutrition based on the questionnaires MUST, NRS-2002 and Nutriscore at baseline and at the end of therapy. The intervention consisted of an individualized nutritional counseling every 2 weeks. RESULTS: Except for emotional functioning, dyspnea, financial difficulties, dental problems and weight gain, all other scales from the EORTC-QLQ-C30 and -H&N35 deteriorated during (chemo)radiotherapy. At first follow-up, patients of the control group experienced more nausea and vomiting compared to those of the intervention group (p = 0.02). After performing a multivariable model, dental problems at the end of therapy (HR: 1.03; 95% CI: 1-1.06; p = 0.03), HPV negativity (HR: 18.19, 95% CI: 1.61-204.17; p = 0.02), and baseline phase angle (HR: 0.09; 95% CI: 0.01-0.82; p = 0.03) were identified as predictors for overall survival. CONCLUSIONS: Factors influencing overall survival in patients with HNSCC undergoing (chemo)radiotherapy are complex and multifactorial. We were able to identify QoL-related (dental problems), clinical (HPV status) and nutritional (phase angle) factors as negative predictors for survival. This study was registered within the German Clinical Trials Register (DRKS00016862).

Head and neck cancer patients under (chemo-)radiotherapy undergoing nutritional intervention: Results from the prospective randomized HEADNUT-trial.

PURPOSE/OBJECTIVE: Patients with squamous cell carcinoma of the head and neck undergoing (chemo-)radiotherapy are at high risk of malnutrition. Nevertheless, there is still a lack of prospective, randomized trials investigating the influence of nutritional status on therapy-related toxicity and patients' outcome. MATERIALS AND 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 bioelectrical impedance analysis (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 and is still ongoing. 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). CONCLUSIONS: Malnutrition negatively impacts patients' outcome under (chemo-)radiotherapy. Baseline phase angle, posttherapeutic FFMI and albumin level are proposed as reliable indicators for overall survival. This study was registered within the German Clinical Trials Register (DRKS00016862).