Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with Cetuximab (E) or Cisplatin (P).
The investigators hypothesize that about 60% of patients receiving RTX without supplemental PN will suffer from critical weight loss of more than 5% during treatment - supplemental overnight PN might result in significant improvement of the nutritional status .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Standard treatment according to the discretion of the center, any required nutritional support (enteral tube feeding by nasogastric tube or percutaneous endoscopic gastrostomy) when considered necessary is allowed
Patients in interventional Arm B will receive parenteral overnight nutrition with ZentroOLIMEL® 5.7% with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) starting with 15 ml/kg body weight/day. In case of weight loss of more than 5%, dose of ZentroOLIMEL® has to be increased up to 25 ml/kg/body weight/day.
Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)
Cisplatin total dose of \>200 mg administered weekly (40 mg/m2/week) or every three weeks (100 mg/m2 every three weeks) according to local standard; not given in combination with cetuximab
70 Gy / 5 fractions per week, over 7 weeks
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Medizinische Universität Graz, HNO Universitätsklinik
Graz, Austria
Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
Klagenfurt, Austria
Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
Linz, Austria
Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie
Vienna, Austria
Hanuschkrankenhaus
Vienna, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria
Loss of body weight by more than 5% at the end of radiotherapy
Weekly body weight assessments - standardized method for all study sites
Time frame: Difference between baseline and week 8 (after end of RTX)
Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
Determination of parameters on functional nutritional status: fat-free mass (FFM), total body water (TBW), body fat and phase angle will be evaluated by BIA
Time frame: Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX
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