Spots Global Cancer Trial Database for Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

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Trial Identification

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

Official Title: 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

Study ID: NCT02236936

Conditions

Squamous Cell Carcinoma of the Hypopharynx Stage III

Squamous Cell Carcinoma of the Hypopharynx Stage IV

Laryngeal Squamous Cell Carcinoma Stage III

Laryngeal Squamous Cell Carcinoma Stage IV

Oropharyngeal Squamous Cell Carcinoma Stage III

Oropharyngeal Squamous Cell Carcinoma Stage IV

Squamous Cell Carcinoma of the Oral Cavity Stage III

Squamous Cell Carcinoma of the Oral Cavity Stage IV

Locally Advanced Malignant Neoplasm

Interventions

Standard care of parenteral nutrition

Parenteral over night nutrition

Cetuximab

Cisplatin

Radiotherapy

Study Description

Brief Summary: 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).

Detailed Description: 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 .