Randomized clinical trial with an enteral arginine-enhanced formula in early postsurgical head and neck cancer patients

Eur J Clin Nutr. 2004 Nov;58(11):1505-8. doi: 10.1038/sj.ejcn.1601999.


Objective: Patients with head and neck cancer undergoing surgery have a high incidence of postoperative complications. The aim of our study was to investigate whether postoperative nutrition of head and neck cancer patients using an arginine-enhanced formula could improve nutritional variables as well as clinical outcomes.

Design: Randomized clinical trial.

Setting: Tertiary care.

Subjects: A population of 90 patients with oral and laryngeal cancer was enrolled.

Interventions: At surgery, patients were randomly allocated to two groups: (a) patients receiving an arginine-enhanced formula with arginine and fiber (group I) and (b) patients receiving an isocaloric, isonitrogenous formula with fiber enteral formula (group II).

Results: No significant intergroup differences in the trend of the three plasma proteins (albumin, transferrin, prealbumin) and lymphocytes were detected. Gastrointestinal tolerance (diarrhea) was better in group II than I (40% group I and 13% group II: P<0.05). The postoperative complications due to infections were similar in both groups (4% group I and 9% group II: ns). Fistula (wound complication) was less frequent in the enriched nutrition group (5% group I and 11% group II: P<0.05); wound infection was similar in both groups. The length of postoperative stay was better in group I than II (25.8+/-15 days vs 35+/-24.6 days; P<0.05).

Conclusions: In conclusion, arginine-enhanced formula improves fistula rates in postoperative head and neck cancer patients and decreases length of stay.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Arginine / therapeutic use*
  • Diarrhea / epidemiology
  • Enteral Nutrition*
  • Female
  • Head and Neck Neoplasms / surgery
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Postoperative Care
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Treatment Outcome
  • Wound Healing / drug effects


  • Arginine