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

Fresenius Kabi

Status: Completed

Conditions: Enteral Nutrition

Treatments: Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes); Dietary Supplement: Fresubin(R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025167

N-SUP-09-DE

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

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

Treatment:

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

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Fresubin(R)