Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Laryngeal Diseases

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Hypopharyngeal Cancer

Micronutrients

All Drugs and Chemicals

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Cetuximab

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Trace Elements

Antineoplastic Agents, Immunological

Kava

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

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

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

Standard care of parenteral nutrition

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.

Parenteral over night nutrition

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

Radiotherapy

Felix Keil, Prof.Dr.

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 .

Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

Randomized Phase III Study: Supplemental Parenteral Nutrition for Patients With Locally Advanced Inoperable Tumors of the Head and Neck, Receiving Definitive Radiotherapy With Cetuximab or Cisplatin

Handgrip strength measurement, mean value of three consecutive measurements

The number of implanted PEG tubes will be recorded

Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.)

Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria

Dose and dose intensity including delay of scheduled therapy and absolute dose of radiotherapy applied.

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.

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.

Weekly body weight assessments - standardized method for all study sites

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck	NCT02236936	Squamous Cell C... Squamous Cell C... Laryngeal Squam... Laryngeal Squam... Oropharyngeal S... Oropharyngeal S... Squamous Cell C... Squamous Cell C... Locally Advance...	Standard care o... Parenteral over... Cetuximab Cisplatin Radiotherapy	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck	NCT02236936	Squamous Cell C... Squamous Cell C... Laryngeal Squam... Laryngeal Squam... Oropharyngeal S... Oropharyngeal S... Squamous Cell C... Squamous Cell C... Locally Advance...	Standard care o... Parenteral over... Cetuximab Cisplatin Radiotherapy	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie

Spots Global Cancer Trial Database for standard care of parenteral nutrition