Clinical trial · Interventional
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
NCT01025167CI-TRIAL-00003822completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Enteral Nutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fresubin(R) | Dietary Supplement | — | UNRESOLVED |
| Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test
- description
- Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates
- interventionNames
- Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic)
- interventionNames
- Dietary Supplement: Fresubin(R)
Primary outcomes (1)
- measure
- Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDFietkau 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