Clinical trial NCT01025167: The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Keywords: cancer
enteral nutrition
omega-3-fatty acids
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
timeFrame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Secondary outcomes:
measure: Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass
timeFrame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
measure: Hand grip strength
timeFrame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
measure: Quality of Life
timeFrame: Baseline, end of radio-/chemotherapy, day 49 of convalescence period
measure: Gastrointestinal tolerance
timeFrame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden
city: Erlangen
country: Germany
facility: Department of Radiotherapy, University hospital
city: Frankfurt
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt
city: Göttingen
country: Germany
facility: Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen
city: Halle
country: Germany
facility: Klinik für Strahlentherapie, Universitätsklinikum Halle
city: Homburg (Saar)
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes
city: Rostock
country: Germany
facility: Klinik und Poliklinik für Strahlentherapie Universität Rostock
city: Tübingen
country: Germany
facility: Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen
city: Ulm
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm
Study officials:
affiliation: Department of Radiotherapy University hospital of Erlangen
name: Rainer Fietkau, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fietkau R, Lewitzki V, Kuhnt T, Holscher T, Hess CF, Berger B, Wiegel T, Rodel C, Niewald M, Hermann RM, Lubgan D. A disease-specific enteral nutrition formula improves nutritional status and functional performance in patients with head and neck and esophageal cancer undergoing chemoradiotherapy: results of a randomized, controlled, multicenter trial. Cancer. 2013 Sep 15;119(18):3343-53. doi: 10.1002/cncr.28197. Epub 2013 Jun 13.