Chikatoshi Katada1, Saeko Fukazawa2, Mitsuhiro Sugawara3, Yasutoshi Sakamoto4, Kaoru Takahashi5, Akiko Takahashi5, Akinori Watanabe6, Takuya Wada6, Kenji Ishido6, Yasuaki Furue6, Hiroki Harada7, Kei Hosoda7, Keishi Yamashita7,8, Naoki Hiki7, Teruko Sato2, Takafumi Ichikawa9, Masayoshi Shichiri10, Satoshi Tanabe11, Wasaburo Koizumi6. 1. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. ckatada@med.kitasato-u.ac.jp. 2. Department of Nutrition, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 3. Department of Pharmacy, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 4. Kitasato Clinical Research Center, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 5. Department of Nursing, Kitasato University Hospital, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 6. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 7. Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 8. Division of Advanced Surgical Oncology, Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 9. Department of Pathological Biochemistry, School of Allied Health Sciences, Kitasato University, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 10. Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan. 11. Department of Advanced Medicine Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, 1-15-1 Kitasato Minami, Sagamihara, 252-0374, Japan.
Abstract
BACKGROUND: This randomized study was designed to evaluate the clinical effect of an elemental diet during chemotherapy in patients with esophageal cancer. METHODS: The inclusion criteria were as follows: (1) esophageal squamous cell carcinoma, (2) stage IB-IV, (3) schedule to receive docetaxel, cisplatin, and 5-fluorouracil (DCF chemotherapy), (4) 20-80 years old, (5) performance status of 0-2, (6) oral intake ability, and (7) written informed consent. Patients were divided into two groups: the elemental supplementary group and the non-supplementary group. Patients received ELENTAL® (160 g/day) orally 9 weeks after the start of chemotherapy. Primary endpoint was the incidence of grade 2 or higher gastrointestinal toxicity according to the Common Terminology Criteria for Adverse Events, version 4.0. Secondary endpoints were the incidence of all adverse events and the evaluation of nutritional status. RESULTS: Thirty-six patients in the elemental supplementary group and 35 patients in the non-supplementary group were included in the analysis. The incidence of grade 2 or higher gastrointestinal toxicity and all grade 3 or 4 adverse events did not differ significantly between the groups. In the elemental supplementary group, the body weight (p = 0.057), muscle mass (p = 0.056), and blood levels of transferrin (p = 0.009), total amino acids (p = 0.019), and essential amino acids (p = 0.006) tended to be maintained after chemotherapy. CONCLUSION: Nutritional support provided by an amino acid-rich elemental diet was ineffective for reducing the incidence of adverse events caused by DCF chemotherapy in patients with esophageal cancer.
BACKGROUND: This randomized study was designed to evaluate the clinical effect of an elemental diet during chemotherapy in patients with esophageal cancer. METHODS: The inclusion criteria were as follows: (1) esophageal squamous cell carcinoma, (2) stage IB-IV, (3) schedule to receive docetaxel, cisplatin, and 5-fluorouracil (DCF chemotherapy), (4) 20-80 years old, (5) performance status of 0-2, (6) oral intake ability, and (7) written informed consent. Patients were divided into two groups: the elemental supplementary group and the non-supplementary group. Patients received ELENTAL® (160 g/day) orally 9 weeks after the start of chemotherapy. Primary endpoint was the incidence of grade 2 or higher gastrointestinal toxicity according to the Common Terminology Criteria for Adverse Events, version 4.0. Secondary endpoints were the incidence of all adverse events and the evaluation of nutritional status. RESULTS: Thirty-six patients in the elemental supplementary group and 35 patients in the non-supplementary group were included in the analysis. The incidence of grade 2 or higher gastrointestinal toxicity and all grade 3 or 4 adverse events did not differ significantly between the groups. In the elemental supplementary group, the body weight (p = 0.057), muscle mass (p = 0.056), and blood levels of transferrin (p = 0.009), total amino acids (p = 0.019), and essential amino acids (p = 0.006) tended to be maintained after chemotherapy. CONCLUSION: Nutritional support provided by an amino acid-rich elemental diet was ineffective for reducing the incidence of adverse events caused by DCF chemotherapy in patients with esophageal cancer.