NCT02236936

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

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

Type	Name	Description
DIETARY_SUPPLEMENT	Standard care of parenteral nutrition	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
DIETARY_SUPPLEMENT	Parenteral over night 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.
BIOLOGICAL	Cetuximab	Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)
DRUG	Cisplatin	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
RADIATION	Radiotherapy	70 Gy / 5 fractions per week, over 7 weeks

Timeline

• Start date: 2017-02-03
• Primary completion: 2019-07-10
• Completion: 2019-07-10
• First posted: 2014-09-11
• Last updated: 2020-05-01

Locations

7 sites across 1 country: Austria