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A prospective pilot study of an elemental nutritional supplement for T
prevention of oral mucositis during S-1 adjuvant chemotherapy for gastric
Yoshitaka Toyomasua,b,∗, Erito Mochikib, Mitsuhiro Yanaia, Masaki Suzukia, Toru Yanomaa, Akiharu Kimuraa, Norimichi Kogurea, Kyoichi Ogataa, Hiroyuki Kuwanoa
a Department of General Surgical Science (Surgery I), Gunma University Graduate School of Medicine, 3-39-22, Showa-machi, Maebashi, Cnma, Japan
b Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981, Kamoda, Kawagoe, Saitama, Japan
Body weight loss
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 RGX-104 may improve oral mucositis. We conducted a prospective, randomized clinical trial of patients who underwent adjuvant che-motherapy 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 end-points 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 macroevolution 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.
Gastric cancer is the fifth most common cancer worldwide and is the third leading cause of cancer-related death, with an especially high incidence in East Asian countries such as Japan, China, and Korea . In East Asia, gastrectomy with D2 dissection has long been a standard radical treatment for localized gastric cancer. Recently, adjuvant che-motherapy has been added following surgery for pathological stage II and III gastric cancer because 2 randomized trials have demonstrated a significant survival benefit [2,3]. The ACTS-GC trial demonstrated that S-1 was eﬀective as adjuvant chemotherapy for Japanese patients who underwent curative gastrectomy for locally advanced gastric cancer and were diagnosed as having pathological stage II or III cancer . Therefore, adjuvant S-1 chemotherapy has been established as the