Randomized phase II study of clinical effects of ghrelin after esophagectomy with gastric tube reconstruction

Abstract

Background: Ghrelin is a peptide hormone with pleiotropic functions including stimulation of growth hormone secretion and appetite, and its levels decrease after esophagectomy. The aim of this study was to evaluate whether exogenous ghrelin administration can meliorate the postoperative decrease of oral food intake and body weight, which are serious complications after esophagectomy.

Methods: This prospective randomized, placebo-controlled, clinical trial assigned a total of 20 patients with thoracic esophageal cancer who underwent radical operation into either a ghrelin (n =10) or placebo (n =10) group. Synthetic human ghrelin (3 microg/kg) or 0.9% saline placebo was administered intravenously twice daily for 10 days from the day after the start of food intake. The primary end point was calories of food intake. Comparison of appetite and changes in weight and body composition were also made between the 2 groups.

Results: Intake of food calories was greater in ghrelin group than placebo group (mean 874 vs 605 kcal per day; P =.015). The appetite score tended to be greater in ghrelin group than placebo group (P =.094). Loss of weight was less in ghrelin group (-1% vs -3%; P =.019) and this attenuation was due largely to a decrease of lean body weight loss (0% vs -4%; P =.012). No side effects were observed in either groups.

Conclusion: These preliminary results suggest that administration of ghrelin after esophagectomy increased oral food intake and attenuated weight loss together with maintenance of lean body weight.