Evidence map›Paper›PMID 26421292›Full record

Trial reportBioMed research international2015

A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting.

Ka-Rham Kim, Gaeun Kang, Myung-Seo Ki, Hyun-Jeong Shim, Jun-Eul Hwang, Woo-Kyun Bae, Ik-Joo Chung, Jong-Keun Kim, Seongwook Jeong, Sang-Hee Cho

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 10 citations in OpenAlex.

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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

10 authors at 2 institutions in 1 country.

Ka-Rham KimDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Gaeun KangDivision of Clinical Pharmacology, Chonnam National University Hospital, Gwangju 519-763, Republic of Korea.
Myung-Seo KiDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Hyun-Jeong ShimDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Jun-Eul HwangDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Woo-Kyun BaeDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Ik-Joo ChungDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Jong-Keun KimDivision of Clinical Pharmacology, Chonnam National University Hospital, Gwangju 519-763, Republic of Korea ; Department of Pharmacology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Seongwook JeongDepartment of Anesthesiology and Pain Medicine, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Sang-Hee ChoDepartment of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
Chonnam National University · KRChonnam National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).

methodsPatients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy). The pharmacokinetics and pharmacodynamics using RINVR were evaluated.

resultsSeventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. T max (h), C max (ng/mL), and AUClast (ng·h/mL) were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%), two patients (14.3%), and one (5.6%) patient and a delayed CINV on day 7 was found in eight (47%), three (21.4%), and five (27.8%) patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group) and also showed the tendency for decreasing moderate-to-severe CINV.

conclusionsThis study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

Indexed as

Antineoplastic AgentsBenzimidazolesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedNauseaPilot ProjectsTreatment OutcomeVomitingAntineoplastic AgentsBenzimidazolesramosetron

Identifiers

PMID26421292
PMCPMC4573230
OpenAlexW2156998776

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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.