Olanzapine combined with dexamethasone, and palonosetron for preventing nausea and vomiting induced by highly emetogenic chemotherapy : a phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017724

Enrollment

Unknown

Registered

2018-08-10

Start date

2017-10-01

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

nausea and vomiting induced by highly emetogenic chemotherapy

Interventions

Group 1:olanzapine combined anti-nausea scheme

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years male or female; 2. Diagnosis of gynecological cancer; 3. ECOG PS(Eastern Cooperative Oncology Group (ECOG) Performance Status)0-2; 4. Receiving highly emetogenic chemotherapy (cisplatin=70mg/m2epirubicin=90mg/m2 or doxorubicin=60mg/m2 combined with cyclophosphamide=600-1000mg/m2); 5. Normal organs (1) Blood routine examination (without blood transfusion in 14 days): HB=90g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; (2) Blood biochemistry: BIL =2.0mg/dL; ALT and AST <120U/L; Cr=177µmol/LCcr=50ml/min (Cockcroft-Gault Formulation); 6. No nausea or vomiting = 24 hours prior to registration; 7. The doctors plan to use olanzapine combined anti-nausea scheme; 8. The patients volunteer to join in the trial and sign the ICF; 9. Women of child-bearing age must undergo pregnancy test (serum or urine) within 7 days prior to registration and the result is negative; in addition, the patients (male/female) will take appropriate contraceptive measures during the trial.

Exclusion criteria

Exclusion criteria: 1. Concurrent abdominal radiotherapy and use of amifostine; 2. Hepatic and renal insufficiency; 3. Congestive heart failure,uncontrollable arrhythmia, myocardial infarction occurred within 6 months, unstable angina, cerebral stoke or transient ischemic attack; 4. Diabetes mellitus or abnormal glucose tolerance; 5. Combined with intestinal obstruction or other diseases that cause nausea and vomiting; 6. Women who are pregnant, are hoping to become pregnant,are breastfeeding; 7. Uncooperative with the trial because of mental illness or other reasons; 8. Allergy to experimental drugs; 9. Treatment with another antipsychotic agent=30 days prior to registration; 10. Concurrent use of quinolone antibiotic therapy; 11. Chronic alcoholism; 12. Other patients who are unfit for inclusion considered by other physicians.

Design outcomes

Primary

Measure	Time frame
The complete response rate of nausea and vomiting;	—

Countries

China

Contacts

Public ContactXiaomei Li

Chinese PLA General hospital

lixiaomei201306@sina.com+86 13501308592

Outcome results

None listed

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