The efficacy of simple oral nutritional supplements versus usual care in postoperative patients with gastric cancer: study protocol for a multicenter, open-label, parallel, randomized controlled trial
Kohei Ueno,
Tatsuto Nishigori,
Yukinari Tokoro,
Akiyoshi Nakakura,
Shigeru Tsunoda,
Shigeo Hisamori,
Kyoichi Hashimoto,
Seiichiro Kanaya,
Kenjiro Hirai,
Eiji Tanaka,
Hiroaki Hata,
Dai Manaka,
Masazumi Sakaguchi,
Masato Kondo,
Takatsugu Kan,
Atsushi Itami,
Akira Miki,
Yuichiro Kawamura,
Kosuke Toda,
Hiroshi Okabe,
Michihiro Yamamoto,
Yoshito Yamashita,
Yosuke Kinjo,
Hironori Kawada,
Kazutaka Obama,
Kyoto Esophageal, Gastric Cancer Surgery Group (KEGG)
Affiliations
Kohei Ueno
Department of Surgery, Kyoto University Hospital
Tatsuto Nishigori
Department of Surgery, Kyoto University Hospital
Yukinari Tokoro
Department of Surgery, Kyoto University Hospital
Akiyoshi Nakakura
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine
Shigeru Tsunoda
Department of Surgery, Kyoto University Hospital
Shigeo Hisamori
Department of Surgery, Kyoto University Hospital
Kyoichi Hashimoto
Department of Surgery, Uji-Tokushukai Medical Center
Seiichiro Kanaya
Department of Surgery, Osaka Red Cross Hospital
Kenjiro Hirai
Department of Surgery, Japanese Red Cross Otsu Hospital
Eiji Tanaka
Department of Surgery, The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Hiroaki Hata
Department of Surgery, National Hospital Organization Kyoto Medical Center
Dai Manaka
Department of Surgery, Kyoto Katsura Hospital
Masazumi Sakaguchi
Department of Surgery, Kyoto City Hospital
Masato Kondo
Department of Surgery, Kobe City Medical Center, General Hospital
Takatsugu Kan
Department of Surgery, Kobe City Medical Center, West Hospital
Atsushi Itami
Department of Surgery, Kobe City Nishi-Kobe Medical Center
Akira Miki
Department of Surgery, Toyooka Hospital
Yuichiro Kawamura
Department of Surgery, Kokura Memorial Hospital
Kosuke Toda
Department of Surgery, Shiga General Hospital
Hiroshi Okabe
Department of Surgery, New Tokyo Hospital
Michihiro Yamamoto
Department of Surgery, Tenri Hospital
Yoshito Yamashita
Department of Surgery, Japanese Red Cross Wakayama Medical Center
Yosuke Kinjo
Department of Surgery, National Hospital Organization Himeji Medical Center
Hironori Kawada
Department of Surgery, Hyogo Prefectural Amagasaki General Medical Center
Kazutaka Obama
Department of Surgery, Kyoto University Hospital
Kyoto Esophageal, Gastric Cancer Surgery Group (KEGG)
Abstract Background Body weight loss (BWL) after gastrectomy impact on the short- and long-term outcomes. Oral nutritional supplement (ONS) has potential to prevent BWL in patients after gastrectomy. However, there is no consistent evidence supporting the beneficial effects of ONS on BWL, muscle strength and health-related quality of life (HRQoL). This study aimed to evaluate the effects of ONS formulated primarily with carbohydrate and protein on BWL, muscle strength, and HRQoL. Methods This will be a multicenter, open-label, parallel, randomized controlled trial in patients with gastric cancer who will undergo gastrectomy. A total of 120 patients who will undergo gastrectomy will be randomly assigned to the ONS group or usual care (control) group in a 1:1 ratio. The stratification factors will be the clinical stage (I or ≥ II) and surgical procedures (total gastrectomy or other procedure). In the ONS group, the patients will receive 400 kcal (400 ml)/day of ONS from postoperative day 5 to 7, and the intervention will continue postoperatively for 8 weeks. The control group patients will be given a regular diet. The primary outcome will be the percentage of BWL (%BWL) from baseline to 8 weeks postoperatively. The secondary outcomes will be muscle strength (handgrip strength), HRQoL (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L), nutritional status (hemoglobin, lymphocyte count, albumin), and dietary intake. All analyses will be performed on an intention-to-treat basis. Discussion This study will provide evidence showing whether or not ONS with simple nutritional ingredients can improve patient adherence and HRQoL by reducing BWL after gastrectomy. If supported by the study results, nutritional support with simple nutrients will be recommended to patients after gastrectomy for gastric cancer. Trial registration jRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023.
