Randomized study of prevention of gastrointestinal toxicities by nutritional support using an amino acid-rich elemental
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ORIGINAL ARTICLE
Randomized study of prevention of gastrointestinal toxicities by nutritional support using an amino acid‑rich elemental diet during chemotherapy in patients with esophageal cancer (KDOG 1101) Chikatoshi Katada1 · Saeko Fukazawa2 · Mitsuhiro Sugawara3 · Yasutoshi Sakamoto4 · Kaoru Takahashi5 · Akiko Takahashi5 · Akinori Watanabe1 · Takuya Wada1 · Kenji Ishido1 · Yasuaki Furue1 · Hiroki Harada6 · Kei Hosoda6 · Keishi Yamashita6,7 · Naoki Hiki6 · Teruko Sato2 · Takafumi Ichikawa8 · Masayoshi Shichiri9 · Satoshi Tanabe10 · Wasaburo Koizumi1 Received: 12 May 2020 / Accepted: 25 September 2020 © The Japan Esophageal Society 2020
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 E LENTAL® (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. Keywords Elemental diet · Esophageal cancer · DCF · Chemotherapy · Nutrition
Introduction Esophageal cancer had a worldwide incidence of 572,034 and was associated with 508,585 deaths in 2018 [1]. Its outcomes remain poor despite multimodal treatment approaches [2–4]. Chemotherapy followed by surgery has been used as a treatment for resectable esophageal cancer [4–6]. Induction and palliative chemotherapies are also effective for the treatment of borderline and metastatic unresectable esophageal * Chikatoshi Katada [email protected]‑u.ac.jp Extended author information available on the last page of the article
cancers [7–9]. Intensive chemotherapy is necessary to improve the outcomes of esophageal cancer. Recently, multidisciplinary tr
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