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

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).

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

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

Sponsors & Collaborators

• Medical University of Graz

  collaborator OTHER

• Arbeitsgemeinschaft medikamentoese Tumortherapie

  lead OTHER

Principal Investigators

• Felix Keil, Prof.Dr. · Hanuschkrankenhaus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-03

Primary Completion

2019-07-10

Completion

2019-07-10

Countries

• Austria

Study Locations