Evidence map›Paper›PMID 33242754›Full record

Trial reportBreast (Edinburgh, Scotland)2020

A randomized trial of individualized versus standard of care antiemetic therapy for breast cancer patients at high risk for chemotherapy-induced nausea and vomiting.

M Clemons, G Dranitsaris, M Sienkiewicz, S Sehdev, T Ng, A Robinson, M Mates, T Hsu, S McGee, O Freedman and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 9 pooled it
2.7field-weighted citation impact, top 9% 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

23 citing papers in PubMed, 9 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Olanzapine (10 mg vs 5 mg vs 2.5 mg) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) - a systematic review and network meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
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  4. Clinical benefits of adding olanzapine to 5-HTInternational journal of clinical oncology · 2025
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  5. Guideline
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  8. 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
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  10. Trial
  11. 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
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  13. Observational
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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

15 authors at 6 institutions in 1 country.

M ClemonsDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada. Electronic address: mclemons@toh.ca.
G DranitsarisConsultant Biostatistician, 283 Danforth Ave, Toronto, Canada.
M SienkiewiczCancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
S SehdevDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.
T NgDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.
A RobinsonCancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada.
M MatesCancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada.
T HsuDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.
S McGeeDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.
O FreedmanDivision of Medical Oncology, Durham Regional Cancer Centre, Oshawa, Ontario, Canada.
V KumarMarkham Stouffville Hospital, Shakir Rehmatullah Cancer Clinic, Markham, Ontario, Canada.
D FergussonClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.
B HuttonClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.
L VandermeerCancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
J HiltonDepartment of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Ottawa Hospital · CAUniversity of Ottawa · CAKingston General Hospital · CAMarkham Stouffville Hospital · CAOttawa Hospital Research InstituteRegional Municipality of Durham · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDespite triple antiemetic therapy use for breast cancer patients receiving emetogenic chemotherapy, nausea remains a clinical challenge. We evaluated adding olanzapine (5 mg) to triple therapy on nausea control in patients at high personal risk of chemotherapy-induced nausea and vomiting (CINV).

methodsThis multi-centre, placebo-controlled, double-blind trial randomized breast cancer patients scheduled to receive neo/adjuvant chemotherapy with anthracycline-cyclophosphamide or platinum-based chemotherapy to olanzapine (5 mg, days 1-4) or placebo. Primary endpoint was frequency of self-reported significant nausea, repeated for all cycles of chemotherapy. Secondary endpoints included: duration of nausea, overall total control of CINV, Health Related Quality of Life (HRQoL) using FLIE questionnaire, use of rescue mediation and treatment-related adverse events.

results218 eligible patients were randomised to placebo (105) or olanzapine (113). From days 0-5 following each cycle of chemotherapy, 41.3% (95%CI: 36.1-46.7%) of patients in the placebo group reported significant nausea compared to 27.7% (95%CI: 23.2-32.4%) in the olanzapine group (p = 0.001). Across all cycles of chemotherapy, patients receiving olanzapine experienced a statistically significant improvement in HRQoL (p < 0.001). Grade 1/2 sedation was the most commonly side effect reported at 40.8% in the placebo group vs. 54.1% with olanzapine (p < 0.001).

conclusionIn patients at high personal risk of CINV, the addition of olanzapine 5 mg daily to standard antiemetic therapy significantly improves the control of nausea, HRQoL, with no unexpected toxicities.

Indexed as

AdultAgedAged, 80 and overAnthracyclinesAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDouble-Blind MethodFemaleHumansMiddle AgedNauseaOlanzapineQuality of LifeStandard of CareAnthracyclinesAntiemeticsCyclophosphamideOlanzapineBreast cancerChemotherapy-induced nausea and vomitingOlanzapineRisk model

Identifiers

PMID33242754
PMCPMC7695916
OpenAlexW3101785640

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.