Evidence map›Paper›PMID 41706725›Full record

Trial reportThe oncologist2026

Novel antiemetic effect of naldemedine in patients initiating opioids for cancer pain: a secondary analysis of a randomized clinical trial.

Takahiro Higashibata, Takaomi Kessoku, Shinya Kajiura, Mami Hirakawa, Shunsuke Oyamada, Keisuke Ariyoshi, Takeshi Yamada, Yoshiyuki Yamamoto, Toshikazu Moriwaki, Hiroka Nagaoka and 14 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

24 authors.

Takahiro HigashibataDepartment of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.ORCID 0000-0002-1024-1946
Takaomi KessokuDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.
Shinya KajiuraMedical Oncology and Palliative Medicine Department, Toyama University Hospital, Toyama 930-0194, Japan.
Mami HirakawaDepartment of Palliative Medicine, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.
Shunsuke OyamadaDepartment of Biostatistics, Japanese Organisation for Research and Treatment of Cancer (JORTC) Data Center, Tokyo 116-0013, Japan.
Keisuke AriyoshiDepartment of Data Management, JORTC Data Center, Tokyo 116-0013, Japan.
Takeshi YamadaTsukuba Clinical Research & Development Organization (T-CReDO), University of Tsukuba, Tsukuba 305-8576, Japan.
Yoshiyuki YamamotoDepartment of Gastroenterology, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.
Toshikazu MoriwakiDepartment of Gastroenterology and Hepatology, Kurashiki Central Hospital, Kurashiki 710-8602, Japan.
Hiroka NagaokaDepartment of Palliative Care, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo 113-8677, Japan.
Yasuyuki TakashimaTsukuba Clinical Research & Development Organization (T-CReDO), University of Tsukuba, Tsukuba 305-8576, Japan.
Kosuke DokiDepartment of Pharmaceutical Sciences, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.
Bryan J MathisDepartment of Cardiovascular Surgery, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.
Kosuke TanakaDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.
Akiko FuyukiDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.
Atsushi NakajimaDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.
Yo IshiharaDepartment of Palliative Medicine and Gastroenterology, International University Health and Welfare Narita Hospital, Narita 286-8520, Japan.
Ryuji HayashiMedical Oncology and Palliative Medicine Department, Toyama University Hospital, Toyama 930-0194, Japan.
Takayuki AndoThird Department of Internal Medicine, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama 930-0194, Japan.
Yuko KobayashiDepartment of Pharmacy, St. Marianna University Hospital, Kawasaki 216-8511, Japan.
Naoki IzawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.
Yoshiki HorieDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.
Tatsuya MoritaDepartment of Palliative and Supportive Care, Seirei Mikatahara General Hospital, Hamamatsu 433-8558, Japan.
Jun HamanoDepartment of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.ORCID 0000-0003-0304-9881

Funding

University of Tsukuba
6 · The paper itself

Abstract

backgroundSeveral studies have suggested that naldemedine may reduce opioid-induced constipation (OIC) as well as opioid-induced nausea and vomiting (OINV). This study aimed to investigate prophylactic effects of naldemedine on OINV in patients initiating regular, oral, strong opioids for cancer pain.

methodsIn this preplanned secondary analysis of a multicenter, double-blind, randomized, placebo-controlled trial investigating the preventive effects of naldemedine on OIC, eligible patients were randomized in a 1:1 ratio to receive either naldemedine 0.2 mg or placebo once daily for 14 days. The primary endpoint was the complete response (CR) rate, defined as the proportion of patients with no vomiting episodes and no use of rescue antiemetics within the first three days of opioid initiation. The secondary endpoint was the nausea and vomiting score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL).

resultsOf the 103 patients, 48 and 47 patients in each group started protocol treatment, respectively. The CR rate was significantly higher in the naldemedine group than in the placebo group (81.3% vs 38.3%, P < .001). Nausea and vomiting scores on the QLQ-C15-PAL at weeks 1 and 2 were significantly better in the naldemedine group (means 7.1 and 6.4) versus placebo (means 44.6 and 35.3; both P < .001). Within the total effect of naldemedine on the QLQ-C15-PAL nausea and vomiting scores at week 2, the proportion mediated through OIC reduction was 21.9%.

conclusionsNaldemedine may have intrinsic antiemetic potency to prevent both OIC and OINV.

trial registrationhttps://jrct.niph.go.jp/ (Japan Registry of Clinical Trials) Identifier: jRCTs031200397.

Indexed as

Analgesics, OpioidAntiemeticsCancer PainNaltrexoneNauseaNeoplasmsVomitingAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeAnalgesics, OpioidAntiemeticsnaldemedineNaltrexonenaldemedineOICOINVpreventionRCT

Identifiers

PMID41706725
PMCPMC12984443

What OpenQuestion holds

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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.