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Cited by 79Nausea and vomiting managementCancer survivorship and carePain Management and Opioid Use

Olanzapine for the Treatment of Advanced Cancer–Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial

Open access
Navari, Rudolph M., Pywell, Cameron M., Le-Rademacher, Jennifer G., White, Patrick, Dodge, Andrew B., Albany, Costantine, Loprinzi, Charles L.·2020·JAMA Oncology
DOI 10.1001/jamaoncol.2020.1052PMC PMC7206532
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Abstract

Randomized placebo-controlled pilot trial of olanzapine for chronic nausea/vomiting unrelated to chemotherapy in advanced cancer.

Integrity signals

Registry

Crossref · 10.1001/jamaoncol.2020.1052

Cites

18 of 19 references verified0 citation errors · 1 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

3 of 11 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

  • Interpretationcitation

    The magnitude of benefit of olanzapine for nausea/vomiting observed in this trial is in line with what has been reported in 3 other pilot reports.

    “The magnitude of benefit observed in this trial, regarding nausea/vomiting, is in line with what has been reported in 3 other pilot reports.8,12,13”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [8] Passik, 2002, A pilot exploration of the antiemetic activity of olanzapine for the relief of nausea in patients with advanced cancer and pain., J Pain Symptom Manage source
    • cites [12] Harder, 2019, Antiemetic use of olanzapine in patients with advanced cancer: results from an open-label multicenter study., Support Care Cancer source
    • cites [13] MacKintosh, 2016, Olanzapine in the management of difficult to control nausea and vomiting in a palliative care population: a case series., J Palliat Med source
  • Premisecitation

    There is very limited information from randomized clinical trials evaluating effective palliative options for chronic nausea/vomiting in advanced cancer.

    “There is very limited information from randomized clinical trials evaluating effective palliative options for this problem.[1][2][3][4]”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [1] Delgado-Guay, 2009, Symptom distress, interventions, and outcomes of intensive care unit cancer patients referred to a palliative care consult team., Cancer source
    • cites [2] Digges, 2018, Pharmacovigilance in hospice/palliative care: net effect of haloperidol for nausea or vomiting., J Palliat Med source

      The Introduction (page unavailable) says few anti-emetics have evidence to guide palliative care and reports insufficient published randomized-trial evidence for haloperidol specifically. The Clinical Implications section likewise says there were no fully powered randomized trials of haloperidol in palliative care. These passages support a shortage of trial evidence, but do not establish the claim for palliative options generally or specifically for chronic nausea and vomiting in advanced cancer. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [3] Gupta, 2013, Nausea and vomiting in advanced cancer: the Cleveland Clinic protocol., J Support Oncol

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Findingown data

    Olanzapine 5 mg/d for 7 days reduced sedation scores from baseline to day 7 more than placebo (median change 0 vs 0; difference -1; 95% CI, -2 to 0; P = .08).

    “Change from baseline to day 7 0 (-1 to 0) 0 (-1 to 4) -1 (-2 to 0) .08”
    Quote in the paperNot a substantial claim
  • Findingown data

    Olanzapine 5 mg/d for 7 days reduced pain scores from baseline to day 7 more than placebo (median change -1 vs 0; difference -1; 95% CI, -2 to 0; P = .01).

    “Change from baseline to day 7 -1 (-2 to 1) 0 (-3 to 1) -1 (-2 to 0) .01”
    Quote in the paperNot a substantial claim
  • Findingown data

    In patients with advanced cancer and chronic nausea/vomiting unrelated to chemotherapy, olanzapine 5 mg/d for 7 days reduced nausea numeric rating scores from baseline to the last treatment day more than placebo (median change -8 vs -1; difference -8 points; 95% CI, -8 to -7; P < .001).

    “After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm.The primary 2-sided end point P value was <.001.”
    • Also stated in: § Key Points · plain
      “After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm (P < .001).”
    • Also stated in: § Key Points · plain
      “Change from baseline to day 7 -8 (-10 to -6) -1 (-2 to 1) -8 (-8 to -7) <.001”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 7
  • The quote only partly states this claim. 2
  • May combine two claims. 8

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Olanzapine is associated with undesired sedation in some situations.

    “With olanzapine being associated with undesired sedation in some situations, 15 it is interesting to note that there was decreased sedation and improved fatigue in the olanzapine arm.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [15] Navari, 2016, Olanzapine for the prevention of chemotherapy-induced nausea and vomiting., N Engl J Med source

  • The quote only partly states this claim.

    Findingown data

    Olanzapine 5 mg/d for 7 days reduced use of alternative antiemetic drugs compared with placebo.

    “Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.”
    • Also stated in: § Key Points · plain
      “Change from baseline to day 7 -2.0 (-2.0 to 0) 1.0 a NA b NA b”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    No patients receiving olanzapine reported excess sedation or any other adverse event.

    “No patients receiving olanzapine reported excess sedation or any other adverse event.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    All patients on olanzapine continued on it at 5 mg/d, with continued efficacy and no toxic effects attributed to the olanzapine.

    “The results of this inquiry revealed that all the patients on olanzapine continued on it at 5 mg/d, with continued efficacy and no toxic effects attributed to the olanzapine.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The post-study clinician reports of continued efficacy and toxicity are accurate.

  • May combine two claims.

    Findingown data

    Of the 14 patients initially receiving placebo, 13 began olanzapine treatment, and all reported marked efficacy and few or no toxic effects.

    “Of the 14 patients who were initially receiving a placebo, all were offered olanzapine at 5 mg/d; 13 began olanzapine treatment, while 1 patient declined owing to disease progression and inability to take oral medications.All these patients reported marked efficacy and few or no toxic effects.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The post-study clinician reports of continued efficacy and toxicity are accurate.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Data regarding eligibility assessment were not collected.

    “Data regarding eligibility assessment were not collected.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The small sample size is a limitation of the trial.

    “The small sample size in the current trial is clearly a study limitation.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Olanzapine, at 5 mg/d, appeared effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.

    “Olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductnone given

    All entered patients received the appropriate randomly assigned intervention, and no patients were lost to follow-up.

    “All entered patients received the appropriate randomly assigned intervention, and no patients were lost to follow-up.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    The trial was randomized, double-blind, and placebo-controlled.

    “This study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019.”
    • Also stated in: § Methods · plain
      “Protocol patients were randomized to receive olanzapine (5 mg/d, orally, days 1-7) or a placebo.All clinicians interacting with patients and all patients were blinded (eAppendix in Supplement 2).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Olanzapine has appetite-enhancing properties.

    “The improvement in appetite is not surprising, as the appetite-enhancing properties of this drug are well known.14”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] Navari, 2010, Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial., Support Care Cancer source

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    All patients were included in the analyses.

    “All patients were included in the analyses.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The data from this trial support that olanzapine substantially decreases nausea/vomiting associated with advanced cancer and is relatively well tolerated.

    “The data from this trial support that olanzapine substantially decreases nausea/vomiting associated with advanced cancer and is relatively well tolerated.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The study sample is representative of patients with advanced cancer and chronic nausea/vomiting unrelated to chemotherapy.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The primary study end point and the study hypothesis were both identified prior to data collection.

    “The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). The quote only partly states this claim.

    Study design and conductown data

    One patient in the placebo arm stopped treatment early owing to lack of perceived benefit/persistent nausea/vomiting.

    “One patient, on the placebo, stopped treatment early owing to lack of perceived benefit.”
    • Also stated in: § Key Points · plain
      “One patient, who was on the placebo arm, withdrew from the study on day 5 owing to persistent nausea/vomiting.”
    Quote in the paperNot a substantial claim
15 of 15

  • The paper relies on this without support.

    Chronic nausea/vomiting unrelated to chemotherapy is a substantial symptom in patients with advanced cancer.

    “Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.”

  • The paper relies on this without support.

    The study sample is representative of patients with advanced cancer and chronic nausea/vomiting unrelated to chemotherapy.

    “The data from this trial support that olanzapine substantially decreases nausea/vomiting associated with advanced cancer and is relatively well tolerated.”

  • The paper relies on this without support.

    The post-study clinician reports of continued efficacy and toxicity are accurate.

    “Months after the protocol was completed, the protocol patients' clinicians were contacted to inquire about how the patients did following study participation.The results of this inquiry revealed that all the patients on olanzapine continued on it at 5 mg/d, with continued efficacy and no toxic effects attributed to the olanzapine.”
3 of 3

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Placebo antiemetic-dose medians cannot all be correct

    Minor

    The placebo group had 15 patients, and every baseline value was at least 1 dose. If the median change was an increase of 1 dose, at least 8 patients must have taken at least 2 doses on day 7; the day-7 median therefore cannot be 1.5.

  • Antiemetic-use P value is both reported and unavailable

    Minor

    The table says P values for alternative antiemetic doses are unavailable, but the figure displays a P value for antiemetic usage. Its caption says the displayed P values test the same baseline-to-day-7 comparison.

2 of 2

Cites

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Related

Authors
Navari, R. M., Pywell, C. M., Le-Rademacher, J. G., White, P., Dodge, A. B., Albany, C., & Loprinzi, C. L.
Affiliations
  • University of Alabama at Birmingham (US)
  • Mayo Clinic, Rochester, Minnesota
  • Washington University in St. Louis (US)
  • Mayo Clinic (US)
  • Indiana University School of Medicine (US)
Corresponding author
Loprinzi, Charles L.
ORCID
Venue
JAMA Oncology
Publisher
American Medical Association (AMA)
Published
2020-06-01
Volume
6
Issue
6
Pages
895
ISSN
2374-2437 (ISSN-L)
DOI
10.1001/jamaoncol.2020.1052
PMC
PMC7206532
OpenAlex
W3021250419
Cited by
78
References
17
Citations by year
2026: 7 · 2025: 10 · 2024: 17 · 2023: 10 · 2022: 12 · 2021: 16 · 2020: 6
FWCI
10.04
Type
journal article
Language
en
Open access
Locations
  • JAMA Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • IUScholarWorks (Indiana University) (submittedVersion)
Funders
National Cancer Institute (UG1CA189823)
Topics
  • Health Sciences › Medicine › Surgery › Nausea and vomiting management
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
Keywords
olanzapine, chronic nausea, vomiting, advanced cancer, antiemetic therapy, patient-reported outcomes, appetite, sedation, fatigue, well-being, atypical antipsychotics, treatment tolerability, adverse events
MeSH terms
Olanzapine, Adult, Aged, Antiemetics, Double-Blind Method, Female, Humans, Male, Middle Aged, Nausea, Neoplasms, Pilot Projects, Vomiting

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-11.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-11.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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