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

NCT ID: NCT02236936


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
Purpose
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).
Details
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 .
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
Keywords
Squamous Cell Carcinoma, Head and neck, SCCHN, Parenteral nutrition, Larynx, Hypopharynx, Cavum oris, Radiotherapy, Cetuximab, Cisplatin
Source
Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsors
Arbeitsgemeinschaft medikamentoese Tumortherapie, Medical University of Graz
Status
Not yet recruiting
Acronym
AGMT_HNO_PN
Last Updated
21 Dec 2016
URL
Official Link
Locations
Austria