Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical Trial
Qinghai Red Cross Hospital
230 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
Summary
This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival.
Eligibility
Inclusion Criteria7
- Aged 18 years or older;
- Eastern Cooperative Oncology Group performance status of 0-3;
- Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;
- Subjected to palliative systemic chemotherapy, regardless of first-line or second-line treatment;
- Expected survival ≥ 3 months;
- The patient is eligible for oral administration without dietary restrictions;
- Exhibits a favorable adherence to treatment and follow-up, demonstrates compliance with the research protocol, and willingly signs the informed consent form.
Exclusion Criteria9
- Weight loss and gain may be attributed to alternative factors, such as edema or ascites;
- Suffers from mental disorders or is under the medication of any antipsychotic or antidepressant drugs;
- History of central nervous system disorders (such as brain metastasis, epilepsy;
- Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those with substance dependence on medications;
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
- History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
- Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
- Pregnant and Nursing women;
- Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study.
Interventions
Oral olanzapine 2.5 mg once daily at bedtime until disease progression
Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation
All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06338683