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Chemotherapy-induced Nausea and VomitingPhase 3NCT05805800

Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

A Phase 3 study testing 5HT3RA+Olanzapine and 5HT3RA+Olanzapine+Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Xingchen Peng at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
5HT3RA+Olanzapine and 5HT3RA+Olanzapine+Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
1 siteChina
Study dates
15 Apr 2023to 15 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 years of age or older with malignant disease；
  • Life expectancy ≥ 3 months;
  • Scheduled to receive highly emetogenic chemotherapy；
  • Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Who cannot join

  • There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
  • History of central nervous system disease (e.g., brain metastases or a seizure disorder);
  • Severe cognitive impairment；
  • Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
  • Concurrent use of pharyngeal or abdominal radiotherapy;
  • Concurrent use of quinolone antibiotics;
Show all 14Show fewer
  • Concurrent use of Amifostine;
  • Chronic alcoholism;
  • Known hypersensitivity to olanzapine;
  • Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
  • Known uncontrolled diabetes mellitus;
  • Vomiting or retching 24 hours before chemotherapy;
  • Use of anti-emesis drugs 48 hours before chemotherapy;
  • Patients who require medication with dexamethasone for pretreatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent Nausea and Vomiting Induced by Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.

Being tested
5HT3RA+Olanzapine, 5HT3RA+Olanzapine+Dexamethasone
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5HT3RA+OlanzapineDrug

    Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.

    On day 1-4, Olanzapine is delivered orally after dinner.

  • 5HT3RA+Olanzapine+DexamethasoneDrug

    Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.

    On day 1-4, Olanzapine is delivered orally after dinner. On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.

Study groups in NCT05805800
Study groupRoleWhat they receive
5HT3RA+OlanzapineExperimentalUsing one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.
Receives: Drug: 5HT3RA+Olanzapine
5HT3RA+Olanzapine+DexamethasoneActive comparatorUsing one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.
Receives: Drug: 5HT3RA+Olanzapine+Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 0-120h Complete Remission Rate

    The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.

    Measured: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Secondary outcomes (2)

  1. 25-120 hours Complete Remission Rate

    The ratio of patients who have no vomiting and apply no anti-nausea drugs during the 25-120 hours observation period.

    Measured: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

  2. 0-120h No Nausea Rate

    The ratio of patients who have no nausea during the whole observation period.

    Measured: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2023
  2. Study start15 Apr 2023
  3. Primary completion30 Apr 2024
  4. Study completion15 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05805800
Sponsor's protocol ID
2023-157
Status last verified
May 2025
First submitted
27 Mar 2023
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ng TL, Hutton B, Clemons M. Chemotherapy-Induced Nausea and Vomiting: Time for More Emphasis on Nausea? Oncologist. 2015 Jun;20(6):576-83. doi: 10.1634/theoncologist.2014-0438. Epub 2015 May 6.

    PubMed 25948677

  • Yang LQ, Sun XC, Qin SK, Cheng Y, Shi JH, Chen ZD, Wang QM, Zhang HL, Hu B, Liu B, Zhang QY, Wu Q, Wang D, Shu YQ, Dong J, Han BH, Wang KM, Dang CX, Li JL, Wang HB, Li BL, Lu JG, Zhang ZH, Chen YX. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017 Nov;26(6):e12668. doi: 10.1111/ecc.12668. Epub 2017 Apr 10.

    PubMed 28393417

  • Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

    PubMed 24276953

  • Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.

    PubMed 19775450

  • Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

    PubMed 27410922

  • Chelkeba L, Gidey K, Mamo A, Yohannes B, Matso T, Melaku T. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis. Pharm Pract (Granada). 2017 Jan-Mar;15(1):877. doi: 10.18549/PharmPract.2017.01.877. Epub 2017 Mar 15.

    PubMed 28503222

  • Chen S, Pei YY, Zhang HW, Chen Y, Deng LC, Chen X, Wei ZG, Li D, Li ZH, Li RD, Liu ZR, Peng XC. Randomized, double-blind phase III trial of a dexamethasone-free regimen for managing highly emetogenic chemotherapy-induced nausea and vomiting. Int J Cancer. 2026 Jan 1;158(1):131-139. doi: 10.1002/ijc.70069. Epub 2025 Jul 30.

    PubMed 40735921

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5HT3RA+Olanzapine and 5HT3RA+Olanzapine+Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Xingchen Peng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

0-120h Complete Remission Rate (time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05805800, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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