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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01025167
Other study ID # N-SUP-09-DE
Secondary ID
Status Completed
Phase N/A
First received December 2, 2009
Last updated August 19, 2010
Start date September 2006
Est. completion date January 2010

Study information

Verified date August 2010
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)
500 ml per day / treatment period 11-14 weeks
Fresubin(R)
500 ml/a nutritionally complete enteral standard feed (isoenergetic)

Locations

Country Name City State
Germany Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO Bremen
Germany Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden Dresden
Germany Department of Radiotherapy, University hospital Erlangen
Germany Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt Frankfurt
Germany Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen Göttingen
Germany Klinik für Strahlentherapie, Universitätsklinikum Halle Halle
Germany Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes Homburg (Saar)
Germany Klinik und Poliklinik für Strahlentherapie Universität Rostock Rostock
Germany Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen Tübingen
Germany Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Hand grip strength Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period No
Secondary Quality of Life Baseline, end of radio-/chemotherapy, day 49 of convalescence period No
Secondary Gastrointestinal tolerance Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily No
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