Trial Information

Preoperative Nutrition Support in Major Oncologic Surgery

HYPOTHESIS:

Patients receiving enteral nutrition support with immune-enhancing formulas (containing
higher concentrations of arginine, glutamine and omega 3 fatty acids compared with standard
polymeric formulas) during 7 days before a major oncological surgical procedure, have a
lower incidence of nutritional-related postoperative complications, compared with patients
without preoperative nutritional supplementation or those supplemented with standard
formulas.

OBJECTIVES:

- To put in practice a routine nutritional assessment for every patient that is going to
be submitted to major digestive oncologic surgery

- In these patients evaluate adherence and tolerance of enteral drinks, comparing
immune-enhancing with the standard polymeric formulations, during 7 days prior to
surgery

- To compare frequency of postoperative nutrition-related complications (infections,
anastomotic leaks and hospital length of stay), among non-supplemented patients and
those receiving preoperative immune-enhancing or standard polymeric formulas.

PATIENTS AND METHODS:

Every patient proposed for major elective digestive oncologic surgery will be invited to a
nutritional assessment. Exclusion criteria will be emergency surgery or renal failure (serum
creatinine over 1.5 mg/dL). Some patients will not accept or will not be able to attend for
several reasons, however they will be assessed by the clinical nutritionist the day of
admission, before entering the OR, and followed as the other study patients, and will be
considered the control group. Nutritional assessment will include clinical story, dietary
recall, Global Subjective Assessment (GSA), calculation of percent weight loss respect
habitual weight, anthropometric measurements (height, weight, body mass index) and hand grip
strength. Functional involvement will be studied by the Karnofsky score. Among laboratory
analysis total proteins, albumin, creatinine, BUN and blood cells for lymphocyte count will
be included. All data will be registered in a special chart and then emptied in a
computational data base.

After the nutritional assessment, both well nourished and undernourished patients will be
instructed to consume an enteral drink, orally or by gastrostomy or enteral feeding tube,
during 7 days before surgery. Seventy patients will receive 1 lt per day of a standard
polymeric formula (Fresubin 22%, which gives 1000 Kcal and 35 g protein, does not contain
free aminoacid nor omega fatty acids, and contains glutamine and arginine concentrations of
milk proteins. In order to increase protein intake, 50 g /día of Proteinex R will be added
in this group). The other 70 patients will be instructed to consume 600 ml of the special
immune-enhancing formula plus 20 g glutamine (Supportan R + Glutamine plus R , which contain
900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3
fatty acids, in a lower volume due to its higher energy density). Both products are
enriched with essential vitamins and minerals. The enteral formulas will be assigned through
randomized computer-generated numbers, in an open way. Patients that do not agree to
participate, do not have enough time before the operation, do not tolerate the product and
drink less than 100 cc/day will be considered control subjects. The enteral products will be
sold to the patients directly at the oncologic clinic, both the same prize, and lower to
marketing prizes, due to the participation of Fresenius-Kabi in the protocol. However if the
patients does not have the means, will receive it for free. All patients will be instructed
to maintain their previous diet, adding the enteral supplement, or completing their
requirement by tube feeding with standard or specific formulations (e.g. diabetic
formulation).

All patients will be followed during the entire postoperative period, registering days of
stay at the critical ward, time of mechanical ventilation, days of fever, infections (wound,
intra-abdominal, pulmonary, urinary, etc), anastomotic leaks and time of hospitalization.

The participation of Fresenius-Kabi will consist of:

- Paying the enteral formulas, thus avoiding payment for patients (considering that
Fundación Arturo Lopez Perez is a private institution, where patients must pay for
their treatment, according to their health insurance, which usually exclude nutritional
products).

- Collaboration with data registry (nutritional assessment, adherence to the supplements,
postoperative complications, etc.) due to the incorporation of one of their
professionals (nutritionist) to the study.