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Randomized Controlled Trial
Randomized study of the effect of synbiotics during neoadjuvant chemotherapy on adverse events in esophageal cancer patients.
- Masaaki Motoori, Masahiko Yano, Hiroshi Miyata, Keijiro Sugimura, Takuro Saito, Takeshi Omori, Yoshiyuki Fujiwara, Norikatsu Miyoshi, Hirofumi Akita, Kunihito Gotoh, Hidenori Takahashi, Shogo Kobayashi, Shingo Noura, Masayuki Ohue, Takashi Asahara, Koji Nomoto, Osamu Ishikawa, and Masato Sakon.
- Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan. Electronic address: mmotoori@gh.opho.jp.
- Clin Nutr. 2017 Feb 1; 36 (1): 93-99.
Background And AimsThe clinical value of synbiotics in patients receiving neoadjuvant chemotherapy currently remains unclear. The aim of this study was to investigate the effects of synbiotics in esophageal cancer patients receiving neoadjuvant chemotherapy on the intestinal microbiota and the adverse events of chemotherapy.MethodsSixty-one patients with advanced esophageal cancer who were scheduled to receive neoadjuvant chemotherapy were randomly allocated to 2 groups. One group received synbiotics during chemotherapy (n = 30), while the other group did not (n = 31). The fecal microbiota and organic acid concentrations were analyzed. The primary endpoint was the incidence of chemotherapy-related adverse events.ResultsThe numbers of beneficial and harmful bacteria were significantly larger and smaller, respectively, in the synbiotics group than in the control group on day 10 of chemotherapy. The concentrations of acetic acid and propionic acid were significantly higher in the synbiotics group on day 10 of chemotherapy. The frequencies of severe lymphopenia and diarrhea were significantly less in the synbiotics group than in the control group (P = 0.033, 0.035, respectively). Furthermore, febrile neutropenia occurred less in the synbiotics group (10/30 in the synbiotics group vs 19/31 in the control group, P = 0.029).ConclusionsSynbiotics during neoadjuvant chemotherapy in esophageal cancer patients reduced the occurrence of adverse events of chemotherapy through adjustments to the intestinal microbiota. (University Hospital Medical Information Network (http://www.umin.ac.jp), registration number UMIN000006875).Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
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