Evidence map›Paper›PMID 30488222›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2019

Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial.

J Herrstedt, Y Summers, K Jordan, J von Pawel, A H Jakobsen, M Ewertz, S Chan, J D Naik, M Karthaus, S Dubey and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01857232 (Randomised, Double-blind, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT01857232 phase2completednot on this map

Randomised, Double-blind, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide (AC)-Based Chemotherapy

TypeinterventionalSponsorAcacia Pharma LtdRan2013 to 2015Enrolled342ConditionsCINVArmsOndansetron, Placebo, Dexamethasone, Fosaprepitant, APD403 IV
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Guideline
  2. 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  3. Pooled it
  4. Global inequitable distribution of seminal studies of chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. 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

12 authors at 10 institutions in 3 countries.

J HerrstedtDepartment of Oncology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. jherr@regionsjaelland.dk.ORCID http://orcid.org/0000-0002-8844-6546
Y SummersPulmonary Oncology Unit, University Hospital of South Manchester, Manchester, UK.
K JordanDepartment of Oncology/Haematology, Halle (Saale) University Clinic, Halle (Saale), Germany.
J von PawelPulmonology Clinic, Asklepios Specialist Clinic, Gauting, Munich, Germany.
A H JakobsenDepartment of Oncology, Herlev University Hospital, Copenhagen, Denmark.
M EwertzDepartment of Oncology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
S ChanAcademic Unit of Oncology, Nottingham University Hospitals, Nottingham, UK.
J D NaikDepartment of Medical Oncology, Mid Yorkshire NHS Trust, Wakefield, UK.
M KarthausHaematology, Oncology and Palliative Medicine Department, Neuperlach Clinic, Munich, Germany.
S DubeyDepartment of Oncology, Derriford Hospital, Plymouth, UK.
R DavisCancer Clinical Trials Office, Wexham Park Hospital, Slough, UK.
G M FoxDepartment of Clinical Development, Acacia Pharma Ltd, Cambridge, UK.
University of Southern Denmark · DKAcacia Pharma (United Kingdom) · GBAsklepios Fachkliniken München-Gauting · DEDerriford Hospital · GBHeidelberg University · DEHerlev Hospital · DKMid Yorkshire Hospitals NHS Trust · GBMünchen Klinik Neuperlach · DENottingham University Hospitals NHS Trust · GBWexham Park Hospital · GB

Funding

Acacia Pharma Ltd (UK) Not applicable
6 · The paper itself

Abstract

purposeChemotherapy-induced nausea and vomiting (CINV) remain significant clinical problems, especially in the delayed phase (24-120 h after chemotherapy). Amisulpride is a dopamine D

methodsChemotherapy-naïve patients receiving cisplatin ≥ 70 mg/m

resultsThree hundred eighteen subjects were evaluable per protocol. CR rate (24-120 h) was 20% with placebo and 46% with 10 mg amisulpride (p = 0.006 after multiplicity adjustment); in the three-drug control group, it was 59%. Emesis, nausea and 0-120-h CR rate were significantly improved with 10 mg amisulpride compared to placebo. Higher doses of amisulpride were not more effective than 10 mg. In patients with acute phase CR, delayed phase CR rate was 44% for placebo, 75% for 10 mg amisulpride (p = 0.022) and 70% for the 3-drug control. No significant differences were seen between groups in safety parameters.

conclusionsAmisulpride 10 mg orally is safe and superior to placebo at preventing delayed CINV caused by highly emetogenic chemotherapy.

trial registrationNCT01857232.

Indexed as

AdultAgedAmisulprideAnthracyclinesAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCisplatinCyclophosphamideDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInduction ChemotherapyMaleMiddle AgedAmisulprideAnthracyclinesAntiemeticsCisplatinCyclophosphamideOndansetronAmisulprideAnthracycline-cyclophosphamideChemotherapyCisplatinNauseaVomiting

Identifiers

PMID30488222
OpenAlexW2902971283

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.