br standard therapy for stage II and
standard therapy for stage II and III gastric cancer in Japan. The aim of adjuvant chemotherapy is to eradicate micrometastatic tumor cells; to do so, it is essential to continue chemotherapy for a minimal length of time. However, continuation of S-1 is sometimes diﬃcult for patients who are unable to maintain satisfactory oral feeding. For example, the ACTS-GC trial showed that the continuation rate of S-1 administration was 65.8% at 12 months after surgery .
Although the relationship between the S-1 continuation rate and prognosis remains unclear, lower compliance with S-1 might lead to an unfavorable prognosis. The most common cause of withdrawal was the occurrence of adverse events. It is important to identify risk factors for the continuation of S-1 adjuvant chemotherapy, because physicians can then support patients accordingly. Several retrospective studies pointed out that body weight loss after surgery, older age, and complications
after surgery are independent risk factors [4,5]. However, there are few prospective studies that have investigated the continuation of S-1 ad-juvant chemotherapy.
Oral mucositis is an acute ulcerative VH-298 of the oral mu-cosa associated with direct drug toxicity and myelosuppression. Approximately 50% of patients undergoing S-1 adjuvant chemotherapy for gastric cancer develop the condition . Oral mucositis is a dis-tressing condition because of severe pain and bleeding, which may compromise oral hygiene and nutrition and increase the risk of local or systemic infection. Thus, oral mucositis can lead to reduction of che-motherapy dosage or outright discontinuation. However, no methods of prevention have yet been well established. Recently, some reports showed that the elemental diet preparation Elental® may prevent oral mucositis in patients undergoing chemotherapy for esophageal and colorectal cancer [7,8].
We conducted a prospective, randomized clinical trial of patients who underwent adjuvant chemotherapy for gastric cancer to see how nutritional support with amino acids influenced adverse eﬀects asso-ciated with chemotherapy. We used Elental® (Ajinomoto Pharmaceutical Co. Ltd, Tokyo, Japan) because this agent is one of the most popular nutrition products and contains a well-balanced blend of amino acids and minerals.
This article is a preliminary report evaluating the eﬀectiveness of oral nutritional support with amino acids for prevention of che-motherapy-induced oral mucositis or diarrhea.
2. Patients and methods
Patients were eligible for this study if they met the following in-clusion criteria: histologically proven gastric cancer, clinical stage II or
III disease, age from 20 to 80 years, an Eastern Cooperative Oncology Group performance status of 0–2, curative resection, no prior che-motherapy or radiation therapy, and no history of gastrectomy or other malignancy (except uterine cervical carcinoma in situ and focal color-ectal adenocarcinoma) during the past 5 years. Exclusion criteria in-cluded severe heart disease, interstitial pneumonia or pulmonary fi-brosis, bleeding tendency, liver cirrhosis or active hepatitis, chronic renal failure, severe diabetes (HbA1c > 9.0%), and severe drug allergy. All patients gave written informed consent before undergoing rando-mization.
All patients had undergone curative distal or total gastrectomy for gastric adenocarcinoma at Gunma University Hospital from November 2011and to September 2014. Patients were invited to participate in the study after they underwent surgery.
The authors recruited 40 patients according to the described cri-teria, and 22 of these patients participated in the present study (Fig. 1). This study was approved by the Institutional Review Board of the Gunma University Graduate School of Medicine and was in accordance with the ethical guidelines of the Declaration of Helsinki.