PT - JOURNAL ARTICLE AU - KOTARO YAMASHITA AU - YASUHIRO MIYAZAKI AU - DAISAKU NAKATANI AU - YASUNORI MASUIKE AU - KOJI TANAKA AU - KEIJIRO SUGIMURA AU - TOMOKI MAKINO AU - OSAMU SHIRAISHI AU - TSUYOSHI TAKAHASHI AU - YUKINORI KUROKAWA AU - MAKOTO YAMASAKI AU - HIROSHI MIYATA AU - YUTAKA KIMURA AU - HIROYUKI ARAKI AU - TOMOMI YAMADA AU - TAKUSHI YASUDA AU - MASAHIKO YANO AU - HIDETOSHI EGUCHI AU - YUICHIRO DOKI TI - OSK-0028 in Patients With Esophageal Cancer Undergoing Esophagectomy: A Double-blind, Randomised Controlled Trial AID - 10.21873/anticanres.15182 DP - 2021 Aug 01 TA - Anticancer Research PG - 3875--3884 VI - 41 IP - 8 4099 - http://ar.iiarjournals.org/content/41/8/3875.short 4100 - http://ar.iiarjournals.org/content/41/8/3875.full SO - Anticancer Res2021 Aug 01; 41 AB - Background/Aim: An excessive postoperative inflammatory response is correlated with the development of pneumonia and an unfavourable prognosis in patients undergoing esophagectomy for esophageal cancer. We assessed the influence of OSK-0028, a synthetic human ghrelin on inflammatory response and energy metabolism, on the postoperative course of patients following radical esophagectomy. Patients and Methods: Esophageal cancer patients were randomly assigned to low-dose (LD; 0.25 μg/kg/h) or high-dose (HD; 0.5 μg/kg/h) intravenous OSK-0028 or placebo for 7 days after esophagectomy. The primary endpoint was serum interleukin-6 level on postoperative day (POD) 3. Results: A total of 75 patients were enrolled (23 LD, 26 HD, 26 placebo). The median interleukin-6 levels on POD 3 were 40.95, 35.85, and 64.50 pg/ml in the placebo, LD, and HD groups, respectively, with no significant differences (p=0.78). Postoperative complications did not differ between groups. Bodyweight loss was significantly lower in patients receiving OSK-0028 than in those receiving placebo (–0.17% vs. 1.78%, p=0.043). Conclusion: Although OSK-0028 did not attenuate inflammatory response after esophagectomy, it prevented postoperative bodyweight loss.