Evidence map›Paper›PMID 31278102›Full record

ArticleBMJ open2019

Clinical trial protocol of doublet therapy and olanzapine for carboplatin-induced nausea and vomiting in patients with thoracic cancer: a multicentre phase II trial.

Hirotoshi Iihara, Mototsugu Shimokawa, Takenobu Gomyo, Yukiyoshi Fujita, Tsutomu Yoshida, Norihiko Funaguchi, Koichi Minato, Daizo Kaito, Tomohiro Osawa, Momoko Yamada and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. 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
0.2field-weighted citation impact, top 42% of its field
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, 4 citations in OpenAlex.

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

13 authors at 6 institutions in 1 country.

Hirotoshi IiharaDepartment of Pharmacy, Gifu University Hospital, Gifu, Japan.
Mototsugu ShimokawaCancer Biostatistics Laboratory, Clinical Research Institute, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan.
Takenobu GomyoDepartment of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.
Yukiyoshi FujitaDivision of Pharmacy, Gunma Prefectural Cancer Center, Ohta, Japan.
Tsutomu YoshidaDepartment of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, Gifu, Japan.
Norihiko FunaguchiDepartment of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.
Koichi MinatoDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Gifu, Japan.
Daizo KaitoDepartment of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.
Tomohiro OsawaDepartment of Pharmacy, Gifu Municipal Hospital, Gifu, Japan.
Momoko YamadaDepartment of Pharmacy, Asahi University Hospital, Gifu, Japan.
Chiemi HiroseDepartment of Pharmacy, Gifu University Hospital, Gifu, Japan.
Akio SuzukiDepartment of Pharmacy, Gifu University Hospital, Gifu, Japan.
Yasushi OhnoDepartment of Cardiology and Respirology, Gifu University Graduate School of Medicine, Gifu, Japan.
Gifu University · JPGifu Municipal Hospital · JPGifu University Hospital · JPAsahi University · JPGifu Pharmaceutical University · JPNational Hospital Organization Kyushu Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAdding neurokinin-1 receptor antagonist (NK METHODS AND ANALYSIS: This is an open-label, single-arm, multicentre, phase II trial. Patients who receive CBDCA-based therapies (AUC ≥5) and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive a combination of GRN, DEX and OLZ. The primary endpoint is complete response (CR) rate, defined as the absence of emetic episodes and no use of rescue medication for 120 hours after the initiation of CBDCA. Forty-eight patients are required based on our hypothesis that this regimen can improve CR rate from 65% (null hypothesis) to 80% (alternative hypothesis) with a one-sided type I error of 0.1 and a power of 0.8. We set the target sample size at 50 considering dropouts. ETHICS AND DISSEMINATION: The study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000031267.

Indexed as

AntiemeticsAntineoplastic AgentsCarboplatinNauseaOlanzapineThoracic NeoplasmsVomitingAdultAgedClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicYoung AdultAntiemeticsAntineoplastic AgentsCarboplatinOlanzapinecarboplatinnauseaolanzapinevomiting

Identifiers

PMID31278102
PMCPMC6615793
OpenAlexW2954939981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.