Evidence map›Paper›PMID 38961505›Full record

ArticleTrials2024

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 and 16 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Oral nutritional supplement compliance among hospitalized cancer patients: a cross-sectional study based on the KAP model.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Kohei UenoDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Tatsuto NishigoriDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan. nsgr@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0002-4969-5590
Yukinari TokoroDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Akiyoshi NakakuraDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shigeru TsunodaDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Shigeo HisamoriDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Kyoichi HashimotoDepartment of Surgery, Uji-Tokushukai Medical Center, Kyoto, Japan.
Seiichiro KanayaDepartment of Surgery, Osaka Red Cross Hospital, Osaka, Japan.
Kenjiro HiraiDepartment of Surgery, Japanese Red Cross Otsu Hospital, Shiga, Japan.
Eiji TanakaDepartment of Surgery, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan.
Hiroaki HataDepartment of Surgery, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Dai ManakaDepartment of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.
Masazumi SakaguchiDepartment of Surgery, Kyoto City Hospital, Kyoto, Japan.
Masato KondoDepartment of Surgery, Kobe City Medical Center, General Hospital, Hyogo, Japan.
Takatsugu KanDepartment of Surgery, Kobe City Medical Center, West Hospital, Hyogo, Japan.
Atsushi ItamiDepartment of Surgery, Kobe City Nishi-Kobe Medical Center, Hyogo, Japan.
Akira MikiDepartment of Surgery, Toyooka Hospital, Hyogo, Japan.
Yuichiro KawamuraDepartment of Surgery, Kokura Memorial Hospital, Fukuoka, Japan.
Kosuke TodaDepartment of Surgery, Shiga General Hospital, Shiga, Japan.
Hiroshi OkabeDepartment of Surgery, New Tokyo Hospital, Chiba, Japan.
Michihiro YamamotoDepartment of Surgery, Tenri Hospital, Nara, Japan.
Yoshito YamashitaDepartment of Surgery, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.
Yosuke KinjoDepartment of Surgery, National Hospital Organization Himeji Medical Center, Hyogo, Japan.
Hironori KawadaDepartment of Surgery, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.
Kazutaka ObamaDepartment of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Kyoto Esophageal, Gastric Cancer Surgery Group (KEGG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBody 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.

methodsThis 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 registrationjRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023.

Indexed as

Dietary SupplementsGastrectomyMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicStomach NeoplasmsAdministration, OralAdultAgedFemaleHand StrengthHumansMaleMiddle AgedMuscle StrengthNutritional StatusBody weight lossGastrectomyGastric cancerOral nutritional supplementPatient-reported outcomesQuality of life

Identifiers

PMID38961505
PMCPMC11223300

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.