Trial Information

The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies - A Randomized, Placebo-controlled Pilot Study

Background

Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic
diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress
immune function, exaggerate stress response and cause organ system dysfunction. Increased
susceptibility to infection, protracted wound healing, impaired blood clotting and vessel
wall fragility have been shown to be the leading causes of postoperative morbidity and
mortality in malnourished patients undergoing major surgical resections.

Immuno- or pharmaconutrition, defined as enteral or parenteral nutritional therapy based on
a variety of products, such as omega-3-fatty acids, glutamine, arginine, sulfur-containing
amino acids, nucleotides and anti-oxidants, is thought to have beneficial effects on
postoperative recovery in a wide variety of surgical patients. Studies have shown its
clinical effectiveness in terms of reduced postoperative complications, shortening the
hospital stay and reduced hospitalization costs. Torosian et al. showed that severely
malnourished patients benefit from preoperative nutrition, which reduce postoperative
complications by 20%.

Although there is clinical evidence for the administration of immunonutrition to patients in
the perioperative period, our understanding of the optimal type and time of immunonutrition,
the characteristics of patients that benefit most, as well as the immunological mechanisms
responsible for its beneficial effect is limited.

Objective

To assess in malnourished cancer patients the effect of 30g oral glutamine/day (3 sachets
KABI® glutamine, Fresenius Kabi/day) for a preoperative course of 5 days on:

1. Postoperative morbidity (surgical site infections, pneumonia, sepsis, incidence of
wound and fascial dehiscence, incisional hernia, anastomotic break down)

2. Nutritional status of the patients

3. Postoperative cell damage and inflammatory response

4. Perioperative immunocompetence

Methods

Seven days before surgery, the patients will receive a tetanus booster shot and will be
randomly enrolled in either the 'glutamine group' or into the 'placebo group'. The patients
as well as the responsible surgeons will be blinded.

- Patients in the 'glutamine group' will receive 30g oral glutamine / day for 5 days
before surgery.

- Patients in the 'control group' will receive 30g oral maltodextrin / day for 5 days
before surgery.