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NCT Number: NCT05805800

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

5HT3RA+Olanzapine

Drug

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+Dexamethasone

Drug

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.

Primary outcomes

  1. 0-120h Complete Remission Rate

    Time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

Secondary outcomes

  1. 25-120 hours Complete Remission Rate

    Time frame: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

  2. 0-120h No Nausea Rate

    Time frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy

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

Sponsors and collaborators

Lead sponsor

Xingchen Peng

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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