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A randomized controlled study comparing the effectiveness of the triple olanzapine / dexamethasone regimen in the prevention of nausea and vomiting (CINV) caused by hyperemetic chemotherapy

A randomized controlled study comparing the effectiveness of the triple olanzapine / dexamethasone regimen in the prevention of nausea and vomiting (CINV) caused by hyperemetic chemotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042829
Enrollment
Unknown
Registered
2021-01-29
Start date
2020-04-17
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

experimental group:Fosapistan + Olanzapine + Palonosetron
control group:Fosapitan + Dexamethasone + Palonosetron

Sponsors

The First Affiliated Hospital of Xinxiang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years(including boundary value), no gender restriction; 2. Subjects with solid malignancy confirmed by cytology or histology; 3. Comply with the NCCN guidelines and guidelines for vomiting prevention and treatment related to tumor treatment for hyperemetic chemotherapy; 4. Subjects undergoing primary chemotherapy for tumors; 5. Subject's physical status score (ECOG) 0-2 points (including boundary values); 6. Expected survival time >= 3 months; 7. Subjects can read, understand, and complete research questionnaires and diaries, including visual analog scale (VAS); 8. Subjects understood the study procedures and signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. The subject has a mental disability or severe emotional or mental disorder, which the researcher considers unsuitable for inclusion in this study; 2. Except for malignant tumors, the subject has a history of active infections (such as pneumonia) or any uncontrolled disease (such as diabetic ketoacidosis, gastrointestinal obstruction), or any other disease history and the investigator believes may Interfering with research results or exposing subjects receiving study medication to unnecessary risks; 3. The subject has a digestive system disease that affects oral administration and absorption of the drug; 4. Subjects have concomitant diseases such as systemic fungal infections or uncontrolled diabetes that cannot be taken for 4 days; 5. Subjects should not receive any dose of systemic glucocorticoid therapy (except for the administration of the protocol) within 72 hours before starting antiemetic therapy, but local and inhaled glucocorticoids are allowed; 6. Patients known to be allergic to dexamethasone or olanzapine or other test medications.

Design outcomes

Primary

MeasureTime frame
Complete remission rate of vomiting;Control rate of vomiting;anxiety;Sleeping;Blood sugar;

Countries

China

Contacts

Public ContactMin zhang

The First Affiliated Hospital of Xinxiang Medical College

zhangmin1982@xxmu.edu.cn+86 373-4402543

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026