Enteral Nutrition
Conditions
Keywords
cancer, enteral nutrition, omega-3-fatty acids
Brief summary
The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.
Interventions
DIETARY_SUPPLEMENTSupportan(R) (Disease-specific enteral tube feed, food for special medical purposes)
500 ml per day / treatment period 11-14 weeks
DIETARY_SUPPLEMENTFresubin(R)
500 ml/a nutritionally complete enteral standard feed (isoenergetic)
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body cell mass measured by bioelectrical impedance spectroscopy (BIS) | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period |
Secondary
| Measure | Time frame |
|---|---|
| Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period |
| Hand grip strength | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period |
| Quality of Life | Baseline, end of radio-/chemotherapy, day 49 of convalescence period |
| Gastrointestinal tolerance | Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily |
Countries
Germany
Outcome results
None listed