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Clinical Trial 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).


Clinical Trial 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 . ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Squamous Cell Carcinoma Stage III
  • Laryngeal Squamous Cell Carcinoma Stage IV
  • Locally Advanced Malignant Neoplasm
  • Neoplasms
  • Oropharyngeal Squamous Cell Carcinoma Stage III
  • Oropharyngeal Squamous Cell Carcinoma Stage IV
  • Squamous Cell Carcinoma of the Hypopharynx Stage III
  • Squamous Cell Carcinoma of the Hypopharynx Stage IV
  • Squamous Cell Carcinoma of the Oral Cavity Stage III
  • Squamous Cell Carcinoma of the Oral Cavity Stage IV

NCT number NCT02236936
Study type Interventional
Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact
Status Terminated
Phase Phase 3
Start date February 3, 2017
Completion date July 10, 2019

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