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. 2024 Jul 3;25(1):445.
doi: 10.1186/s13063-024-08169-8.

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  1 , Tatsuto Nishigori  2 , Yukinari Tokoro  1 , Akiyoshi Nakakura  3 , Shigeru Tsunoda  1 , Shigeo Hisamori  1 , Kyoichi Hashimoto  4 , Seiichiro Kanaya  5 , Kenjiro Hirai  6 , Eiji Tanaka  7 , Hiroaki Hata  8 , Dai Manaka  9 , Masazumi Sakaguchi  10 , Masato Kondo  11 , Takatsugu Kan  12 , Atsushi Itami  13 , Akira Miki  14 , Yuichiro Kawamura  15 , Kosuke Toda  16 , Hiroshi Okabe  17 , Michihiro Yamamoto  18 , Yoshito Yamashita  19 , Yosuke Kinjo  20 , Hironori Kawada  21 , Kazutaka Obama  1 ; Kyoto Esophageal, Gastric Cancer Surgery Group (KEGG)
Affiliations

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 et al. Trials. .

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.

Keywords: Body weight loss; Gastrectomy; Gastric cancer; Oral nutritional supplement; Patient-reported outcomes; Quality of life.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of the study design
Fig. 2
Fig. 2
Study schedule
Fig. 3
Fig. 3
Content for the schedule of enrollment and assessments
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References

    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. doi: 10.3322/caac.21492. - DOI - PubMed
    1. Aoyama T, Yoshikawa T, Hayashi T, et al. Risk factors for 6-month continuation of S-1 adjuvant chemotherapy for gastric cancer. Gastric Cancer. 2013;16(2):133–139. doi: 10.1007/s10120-012-0158-1. - DOI - PubMed
    1. Kugimiya N, Harada E, Oka K, et al. Loss of skeletal muscle mass after curative gastrectomy is a poor prognostic factor. Oncol Lett. 2018;16(1):1341–1347. doi: 10.3892/ol.2018.8747. - DOI - PMC - PubMed
    1. Cho I, Son Y, Song S, et al. Feasibility and Effects of a Postoperative Recovery Exercise Program Developed Specifically for Gastric Cancer Patients (PREP-GC) Undergoing Minimally Invasive Gastrectomy. J Gastric Cancer. 2018;18(2):118–133. doi: 10.5230/jgc.2018.18.e12. - DOI - PMC - PubMed
    1. Tawantanakorn T, Phibalyart W, Parakonthun T, et al. Changes in physical components after Gastrectomy for adenocarcinoma of stomach and esophagogastric junction. Siriraj Med J. 2023;75(4):241–249. doi: 10.33192/smj.v75i4.260962. - DOI

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