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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-01-31

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.

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Detailed Description

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Conditions

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Enteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

500 ml per day / treatment period 11-14 weeks

Control

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

Group Type PLACEBO_COMPARATOR

Fresubin(R)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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

500 ml per day / treatment period 11-14 weeks

Intervention Type DIETARY_SUPPLEMENT

Fresubin(R)

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

Intervention Type DIETARY_SUPPLEMENT

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No