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18 Years
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Not Enrolling
Both
Enteral Nutrition

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Trial Information


Inclusion Criteria:



- patients with head & neck cancer or oesophagus cancer,

- enteral nutrition with PEG at least for 14 weeks,

- cancer patients who receive a combined radio-/chemotherapy,

- start of nutritional therapy latest at beginning of the radio-/chemotherapy, body
mass index >=16 and <=30 kg/m2,0

- Kondrup Score>=3 or SGA = B/C,

- life expectancy > 6 months,

- written informed consent.

Exclusion Criteria:

- second active carcinoma,

- severe diarrhea unresponsive to codeine/loperamide,

- positive anti-HIV-test (safety reasons),

- pregnant or lactating women,

- insulin-dependent diabetes mellitus type I and II,

- patients with cardiac pacemaker,

- allergy to contents of the investigational product, to milk protein or to fish oil,

- patient has no PEG,

- participation in concurrent clinical studies with any other investigational
nutritional therapy within one months prior to start of the study,

- intake of muscle growth supportan substances (e.g. anabolics),

- additional fish oil or EPA substitution within the last 4 weeks, SGA status A (well
nourished).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Body cell mass measured by bioelectrical impedance spectroscopy (BIS)

Outcome Time Frame:

Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period

Safety Issue:

No

Principal Investigator

Rainer Fietkau, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiotherapy University hospital of Erlangen

Authority:

Germany: Ethics committee

Study ID:

N-SUP-09-DE

NCT ID:

NCT01025167

Start Date:

September 2006

Completion Date:

January 2010

Related Keywords:

  • Enteral Nutrition
  • cancer
  • enteral nutrition
  • omega-3-fatty acids

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