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

Not Applicable

Completed

• Conditions: Enteral Nutrition

• Registration Number: NCT01025167
• Lead Sponsor: Fresenius Kabi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-19
• Last Update Posted: 2010-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

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, Germany