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Olanzapine versus aprepitant for the prevention of high dose cisplatin -induced nausea and vomiting: a randomized phase III trial.

Olanzapine versus aprepitant for the prevention of high dose cisplatin -induced nausea and vomiting: a randomized phase III trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-14004093
Enrollment
Unknown
Registered
2014-01-08
Start date
2014-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Vomiting

Interventions

Sponsors

The Xiangya 2nd hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. the malignant tumor patients can be treated with chemotherapy, disease is unlimited; 2. chemotherapy drugs including cisplatin in 60 mg/m2. Sequential two cycles of chemotherapy drugs, dose, dosing sequence and dosing method must be completely consistent; 3. patients on chemotherapy cycle don't accept any other chemotherapy drugs during 2-4 day, don't accept experimental design other anti-nausea, composed, psychotropic drugs and hormonal therapy during 1-5 day; 4. patients ages from 18 to 75 years, any gender, KPS 60 or more (see attachment 1 scoring criteria), is expected to survive more than 3 months; 5. blood picture, liver and kidney function (including LDH and AKP), electrocardiogram (ecg) basic normal, comply with the indications of chemotherapy; 6. it should be more than 2 weeks after the last chemotherapy; 7. patients should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. nursing and pregnancy women; 2. added with influences the observation of radiation therapy and other drugs may influence the effect of anti-nausea (such as omeprazole, phosphorus ammonia, etc.); 3. patients have the digestive tract obstruction; 4. patients have severe heart disease, kidney disease, xie dysfunction; 5. people with epilepsy or the use of psychotropic drugs and narcotics; 6. people used anti-nausea drugs or within 24 hours before chemotherapy; 7. people have brain metastasis and intracranial pressure caused by vomiting, or influence the vomiting; 8. Allergic to olanzapine; 9. people have chemotherapy contraindications; 10. people is in 3 months or other clinical subjects.

Design outcomes

Primary

MeasureTime frame
vomiting;

Countries

China

Contacts

Public ContactHu Chunhong
huchunh@medmai.com.cn+86 13508486908

Outcome results

None listed

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