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

Enteral Nutrition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025167
• Other study ID #: N-SUP-09-DE
• 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

• Enteral Nutrition

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