A prospective pilot study of an elemental nutritional supplement for prevention of oral mucositis during S-1 adjuvant chemotherapy for gastric cancer

Abstract

Purposes: Oral mucositis is one of the most common reasons for discontinuation of S-1 adjuvant chemotherapy after radical gastrectomy. Some studies suggest that nutritional support with amino acids may improve oral mucositis. We conducted a prospective, randomized clinical trial of patients who underwent adjuvant chemotherapy for gastric cancer to examine whether an oral elemental diet prevents chemotherapy associated oral mucositis and body weight loss.

Methods: Patients were randomly assigned to a group consuming Elental^® (the treatment group, n = 11) or a control diet group (n = 11). Patients in the treatment group consumed one pack of Elental^® per day during adjuvant chemotherapy. The primary endpoint was the presence and grade of oral mucositis. Secondary endpoints included adherence to Elental^® based on the doses recorded in a diary, changes in nutrition parameters, and frequency and severity of adverse events.

Results: The incidence of oral mucositis was significantly lower in the treatment group (9.1%) than in the control group (27.3%). The median body weight loss in the treatment group was significantly smaller than that in the control group (P = .015). According to Kaplan-Meier estimates the treatment group was significantly associated with high cumulative S-1 continuation rates (log-rank P = .047).

Conclusion: We conclude that the amino-acid-rich elemental diet Elental^® may be useful as a countermeasure for S-1 adjuvant chemotherapy-induced mucositis.

Keywords: Body weight loss; Gastrectomy; S-1 continuation.