Last updated: March 28, 2024
Sponsor: Qinghai Red Cross Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Metastatic Cancer
Treatment
Olanzapine 2.5 MG
Standard anti-tumor treatment
Nutritional advice
Clinical Study ID
NCT06338683
QRCH-2024001
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-linetreatment;
- Expected survival ≥ 3 months;
- The patient is eligible for oral administration without dietary restrictions;
- Exhibits a favorable adherence to treatment and follow-up, demonstrates compliancewith the research protocol, and willingly signs the informed consent form.
Exclusion
Exclusion Criteria:
- Weight loss and gain may be attributed to alternative factors, such as edema orascites;
- Suffers from mental disorders or is under the medication of any antipsychotic orantidepressant drugs;
- History of central nervous system disorders (such as brain metastasis, epilepsy;
- Patients undergoing sustained administration of sedative medications or long-termhormonal therapy, individuals with chronic alcoholism, or those with substancedependence on medications;
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
- History of clozapine-induced agranulocytosis because patients will be at increasedrisk for neutropenia with Olanzapine;
- Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
- Pregnant and Nursing women;
- Exclusion criteria include active participation in another interventional clinicaltrial, ongoing involvement in an observational (noninterventional) clinical trial, orbeing in the survival follow-up phase of an interventional clinical trial;
- Researchers posit that any condition deemed potentially harmful to the subjects orthat might prevent subjects from meeting or adhering to the research requirementsshall not be permissible for inclusion in this study.
Study Design
Total Participants: 230
Treatment Group(s): 3
Primary Treatment: Olanzapine 2.5 MG
Phase: 3
Study Start date:
March 20, 2024
Estimated Completion Date:
March 20, 2028
Study Description
Connect with a study center
Qinghai Red Cross Hospital
Xining, Qinghai 810000
ChinaActive - Recruiting
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