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Study stopped due to low recruitment
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| Name | Class |
|---|---|
| Medical University of Graz | OTHER |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Standard of care | Active Comparator | Standard care of parenteral nutrition (with or without parenteral nutrition during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin |
|
| Arm B - Parenteral over night nutrition | Experimental | Parenteral over night nutrition with ZentroOLIMEL 5.7% parenteral over night with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) 15 ml/kg body weight/day (weight loss >5% from baseline; parenteral nutrition increased up to 25 ml/kg body weight per day) during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care of parenteral nutrition | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of body weight by more than 5% at the end of radiotherapy | Weekly body weight assessments - standardized method for all study sites | Difference between baseline and week 8 (after end of RTX) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of physical strength | Handgrip strength measurement, mean value of three consecutive measurements | Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX |
| Number of implanted PEG tubes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Keil, Prof.Dr. | Hanuschkrankenhaus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Feldkirch | Feldkirch | A-6807 | Austria | |||
| Medizinische Universität Graz, HNO Universitätsklinik |
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| Parenteral over night nutrition | Dietary Supplement | 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. |
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| Cetuximab | Biological | Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x) |
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| Cisplatin | Drug | 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 |
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| Radiotherapy | Radiation | 70 Gy / 5 fractions per week, over 7 weeks |
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The number of implanted PEG tubes will be recorded
| From start of RTX until 3 months after end of RTX |
| Acute toxicity during radiotherapy | Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.) | During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy |
| Chronic toxicity after treatment | Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria | 3 months after end of radiotherapy |
| Dose and dose intensity of radiotherapy | Dose and dose intensity including delay of scheduled therapy and absolute dose of radiotherapy applied. | At start and end of radiotherapy (duration of radiotherapy 7 weeks) |
| Progression-free (PFS) | The study will be finished one year post RTX and clinical al data on PFS will be obtained. In addition, patient will be asked to agree to collection of information regarding PFS even after completion of the trial. | From start until 3 months after end of RTX |
| Overall survival (OS) | The study will be finished one year post RTX and clinical data on OS will be obtained. In addition, patient will be asked to agree to collection of information regarding OS even after completion of the trial. | From start until 3 months after end of RTX |
| Graz |
| A-8036 |
| Austria |
| Klinikum Klagenfurt am Wörthersee, HNO-Abteilung | Klagenfurt | A-9020 | Austria |
| Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie | Linz | 4010 | Austria |
| Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie | Vienna | 1130 | Austria |
| Hanuschkrankenhaus | Vienna | 1140 | Austria |
| Landesklinikum Wiener Neustadt | Wiener Neustadt | 2700 | Austria |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| D006963 | Hyperphagia |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004655 | Emulsions |
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
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