Anastassia Löser1, Jakob Abel2, Laura Magdalena Kutz2, Linda Krause3, Anna Finger2, Franziska Greinert2, Margaret Sommer2, Tessa Lorenz2, Eva Culmann2, Julia von Grundherr4, Luisa Wegert4, Loreen Lehmann2, Gesa Matnjani2, Rudolf Schwarz2, Sophie Brackrock2, Andreas Krüll5, Cordula Petersen6, Cedric Oliver Carl2. 1. University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany. Electronic address: an.loeser@uke.de. 2. University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany. 3. University Medical Center Hamburg-Eppendorf, Institute of Medical Biometry and Epidemiology, Hamburg, Germany. 4. University Medical Center Hamburg-Eppendorf, University Cancer Center Hamburg, Germany. 5. University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany; University Medical Center Hamburg-Eppendorf, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany. 6. University Medical Center Hamburg-Eppendorf, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany; University Medical Center Hamburg-Eppendorf, Outpatient Center of the UKE GmbH, Department of Radiotherapy and Radiation Oncology, Hamburg, Germany.
Abstract
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).
RCT Entities:
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).
Authors: Christine Baldwin; Marian Ae de van der Schueren; Hinke M Kruizenga; Christine Elizabeth Weekes Journal: Cochrane Database Syst Rev Date: 2021-12-21
Authors: Anastassia Löser; Kerstin Ramke; Maximilian Grohmann; Linda Krause; Pia Roser; Franziska Greinert; Anna Finger; Margaret Sommer; Eva Culmann; Tessa Lorenz; Saskia Becker; Marvin Henze; Daniel Schodrok; Julia von Grundherr; Silke Tribius; Andreas Krüll; Cordula Petersen Journal: Strahlenther Onkol Date: 2021-11-01 Impact factor: 3.621