Abstract 1439P
Background
Gastrectomy is essential for the cure of gastric cancer (GC) but induces body weight loss (BWL). Especially, patients who received total gastrectomy (TG) hardly takes food intake. High density liquid diet may have advantage that patients take high calorie with low volume. Therefore, we conducted phase II study to evaluate feasibility and safety of oral nutritional supplementation with high density liquid diet (Uplead®) after TG for patients with GC.
Methods
Enrollment criteria were histologically confirmed resectable GC by TG. When food intake was initiated, additional Uplead® (1 pack, 100 ml including 400 kcal /day) was administered until 28 days after surgery. Primary endpoint is compliance of 28 days-Uplead® (%actual intake against planned intake). Secondary endpoints are %BWL and %lean body mass loss (LBML) at 1 and 3 months after surgery. Sample size was determined by considering expected and threshold values of 80% and 60%, respectively with 10% alpha error and statistical power of 80%.
Results
A total of 35 patients were enrolled between April 2018 and December 2019. Four patients were excluded; 2 by peritoneal metastasis, 1 by allergy for Uplead®, and 1 by preoperative pneumonia. Two patients could not start Uplead® due to anastomotic leakage. Thus, a total of 29 patients who initiated Uplead® was analyzed for safety cohort. Seven patients interrupted Uplead®; 6 by patients‘ refusal due to intolerability to taste and 1 by duodenal stump fistula. Remaining 22 patients completed 28 days-Uplead® including temporary interruption. Although adverse events (≥grade 2) were observed in 10 patients among safety cohort (34.5%), there was no adverse event associated with Uplead®. The median compliance was 25.8% (range: 0 - 92.8%) in the safety cohort. Median BWL at 1 and 3 months after surgery were 7% (range: 3 - 14%) and 13% (range: 2 - 20%), respectively. Median LBML at 1 and 3 months after surgery were 7% (range: -9 - 12%) and 9% (range: -13 – 17%), respectively.
Conclusions
Oral nutritional supplementation with high density liquid diet (Uplead®) could be safely administered in patients who received TG for GC. However, feasibility is limited mainly due to intolerability of taste.
Clinical trial identification
UMIN000032291 2018/04/17.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
KSATTS.
Disclosure
All authors have declared no conflicts of interest.