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The relationship between genetic polymorphism and induction of chemotherapy induced nausea and vomiting with olanzapine triple antiemetic regimen

The relationship between genetic polymorphism and induction of chemotherapy induced nausea and vomiting with olanzapine triple antiemetic regimen

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084269
Enrollment
Unknown
Registered
2024-05-14
Start date
2022-10-05
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Malignant tumor of digestive tract

Interventions

A:Olanzapine was taken orally 5mg every night from the day of chemotherapy for 5 consecutive days, and dexamethasone 10 mg and Panolosetron 0.25 mg were injected intravenously 30 min before chemothera
B:Starting from the day of chemotherapy, oral placebo was administered every night for 5 consecutive days, and dexamethasone 10 mg and Panolosetron 0.25 mg were injected intravenously 30 min before ch

Sponsors

Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: A. patients diagnosed as gastrointestinal malignant tumors by pathology who received initial FOLFOX (oxaliplatin 5-FU/ calcium folinate), FOLFIRI (irinotecan 5-FU/ calcium folinate) or XELOX (oxaliplatin capecitabine) or XELIRI regimen B. Women are between 18 and 70 years old at the time of chemotherapy administration; C. Before chemotherapy, liver and kidney function, blood routine and electrocardiogram were normal,Blood test must meet the requirement of white blood cells > 3.5× 109/L.Granulocyte > 1.5×109 /L, platelet > 85×109/L, alkaline phosphatase < 2.5 times of the upper limit of normal value, cereal C.Transaminase < upper limit of normal value 2.5 times, bilirubin < normal.The upper limit is 1.5 times, and creatinine is less than the upper limit of normal value 1.5 times. D. No history of long-term or excessive drinking (less than 5 times a week or less than 100 g a day) E. No nausea or vomiting symptoms one week before admission. E. Patients received olanzapine combined with palonosetron and dexamethasone triple plan or only palonosetron and dexamethasone double plan to prevent vomiting. F. informed consent and signed consent.

Exclusion criteria

Exclusion criteria: A. Patients who can't take drugs orally B. Patients with nausea or vomiting not related to chemotherapy (such as gastrointestinal obstruction, ascites requiring puncture, brain metastasis or other brain tumors/lesions) C. Patients who cannot receive the standard dose of dexamethasone due to uncontrollable diabetes or gastrointestinal bleeding; D. Patients receiving other antipsychotics or NK1 receptor antagonists E. Patients suffering from serious basic diseases such as severe heart disease and liver and kidney diseases F. Pregnant or lactating patients G. patients with incomplete medical records, patient diaries or FLIE scale

Design outcomes

Primary

MeasureTime frame
Total period, acute period and delayed period of complete protection rate after chemotherapy;

Secondary

MeasureTime frame
Relationship between gene polymorphism;Total, acute, and delayed response rates after chemotherapy;Total, acute, and delayed control rate after chemotherapy;Time of first vomiting;Effects of nausea and vomiting on quality of life;

Countries

China

Contacts

Public ContactQuan fu Li

Ordos Central Hospital

1729259173@qq.com+86 159 3490 6099

Outcome results

None listed

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