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

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT01025167
First received: December 2, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Enteral Nutrition
Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)
Dietary Supplement: Fresubin(R)

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

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Body cell mass measured by bioelectrical impedance spectroscopy (BIS) [ Time Frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass [ Time Frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period ] [ Designated as safety issue: No ]
  • Hand grip strength [ Time Frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, end of radio-/chemotherapy, day 49 of convalescence period ] [ Designated as safety issue: No ]
  • Gastrointestinal tolerance [ Time Frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025167

Locations
Germany
Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO
Bremen, Germany, D-28239
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden
Dresden, Germany, D-01307
Department of Radiotherapy, University hospital
Erlangen, Germany, D-91054
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt
Frankfurt, Germany, D-60590
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen
Göttingen, Germany, D-37075
Klinik für Strahlentherapie, Universitätsklinikum Halle
Halle, Germany, D-06097
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes
Homburg (Saar), Germany, D-66421
Klinik und Poliklinik für Strahlentherapie Universität Rostock
Rostock, Germany, D-18059
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen
Tübingen, Germany, D-72076
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm
Ulm, Germany, D-89081
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Rainer Fietkau, Prof. Dr. Department of Radiotherapy University hospital of Erlangen
  More Information

No publications provided by Fresenius Kabi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Steffen Benzing, Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01025167     History of Changes
Other Study ID Numbers: N-SUP-09-DE
Study First Received: December 2, 2009
Last Updated: August 19, 2010
Health Authority: Germany: Ethics committee

Keywords provided by Fresenius Kabi:
cancer
enteral nutrition
omega-3-fatty acids

ClinicalTrials.gov processed this record on August 19, 2014