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

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.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition
• Intervention / Treatment: Dietary supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes); Dietary supplement: Fresubin(R)

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany, D-28239
    • Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO
  • Dresden, Germany, D-01307
    • Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden
  • Erlangen, Germany, D-91054
    • Department of Radiotherapy, University hospital
  • Frankfurt, Germany, D-60590
    • Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt
  • Göttingen, Germany, D-37075
    • Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen
  • Halle, Germany, D-06097
    • Klinik für Strahlentherapie, Universitätsklinikum Halle
  • Homburg (Saar), Germany, D-66421
    • Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes
  • Rostock, Germany, D-18059
    • Klinik und Poliklinik für Strahlentherapie Universität Rostock
  • Tübingen, Germany, D-72076
    • Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen
  • Ulm, Germany, D-89081
    • Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates	Dietary supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes); 500 ml per day / treatment period 11-14 weeks
Placebo Comparator: Control; Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic)	Dietary supplement: Fresubin(R); 500 ml/a nutritionally complete enteral standard feed (isoenergetic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Rainer Fietkau, Prof. Dr., Department of Radiotherapy University hospital of Erlangen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: cancer; enteral nutrition; omega-3-fatty acids
• Other Study ID Numbers: N-SUP-09-DE