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

Study Overview
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Brief Summary
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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
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Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)
* Dietary Supplement: Fresubin(R)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>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)<br>* 500 ml per day / treatment period 11-14 weeks<br>|
| Placebo Comparator: Control<br>Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic) | Dietary Supplement: Fresubin(R)<br>* 500 ml/a nutritionally complete enteral standard feed (isoenergetic)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteral nutrition, cancer, omega-3-fatty acids