Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01025167
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01025167
Study Brief:
Protocol Section:
NCT01025167