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

NCT01025167 | Completed

• 1 other identifier: N-SUP-09-DE
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 10

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.

Conditions

Enteral Nutrition

Keywords

cancer; enteral nutrition; omega-3-fatty acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Test

EXPERIMENTAL

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)

Control

PLACEBO COMPARATOR

Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic)

Dietary Supplement: Fresubin(R)

Interventions

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

500 ml per day / treatment period 11-14 weeks

Test

Fresubin(R) DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (10)

Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO

Bremen, D-28239, Germany

Location

Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden

Dresden, D-01307, Germany

Location

Department of Radiotherapy, University hospital

Erlangen, D-91054, Germany

Location

Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt

Frankfurt, D-60590, Germany

Location

Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen

Göttingen, D-37075, Germany

Location

Klinik für Strahlentherapie, Universitätsklinikum Halle

Halle, D-06097, Germany

Location

Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes

Homburg (Saar), D-66421, Germany

Location

Klinik und Poliklinik für Strahlentherapie Universität Rostock

Rostock, D-18059, Germany

Location

Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen

Tübingen, D-72076, Germany

Location

Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm

Ulm, D-89081, Germany

Location

Related Publications (1)

• 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.

  PMID: 23765693 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rainer Fietkau, Prof. Dr.

  Department of Radiotherapy University hospital of Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: September 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 20, 2010

Record last verified: 2010-08

Locations

DE (10)