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Completed

NCT Number: NCT01025167

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.

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Key information

Conditions

Enteral Nutrition Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO, Bremen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)

Dietary Supplement

500 ml per day / treatment period 11-14 weeks

Fresubin(R)

Dietary Supplement

500 ml/a nutritionally complete enteral standard feed (isoenergetic)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Hand grip strength

    Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period

  3. Quality of Life

    Time frame: Baseline, end of radio-/chemotherapy, day 49 of convalescence period

  4. Gastrointestinal tolerance

    Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Aug 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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