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Trial Title:
Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
NCT ID:
NCT06338683
Condition:
Advanced Cancer
Olanzapine
Progression Free Survival
Conditions: Official terms:
Disease Progression
Olanzapine
Conditions: Keywords:
advanced cancer
olanzapine
chemotherapy
progression free survival
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olanzapine 2.5 MG
Description:
Oral olanzapine 2.5 mg once daily at bedtime until disease progression
Arm group label:
Arm I (ONS group)
Intervention type:
Drug
Intervention name:
Standard anti-tumor treatment
Description:
Clinicians choose the appropriate standard antitumor drug therapy based on the patient's
specific situation
Arm group label:
Arm I (ONS group)
Arm group label:
Arm II (NS group)
Intervention type:
Dietary Supplement
Intervention name:
Nutritional advice
Description:
All patients enrolled in the study were required to undergo a nutritional assessment and
were provided with nutritional advice based on their condition
Arm group label:
Arm I (ONS group)
Arm group label:
Arm II (NS group)
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.
Detailed description:
This study is a prospective, randomized, multicenter, open-label clinical trial to
evaluate the effect of olanzapine on survival in patients with locally advanced,
unresectable, or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung
cancer. Patients who meet the inclusion and exclusion criteria will be formally enrolled
after screening and signing an informed consent form. Eligible patients will be
dynamically randomized in a 1:1 ratio to either the Olanzapine + Nutritional advice +
Standard anti-tumor treatment group (ONS group) or the Nutritional advice + Standard
anti-tumor treatment group (NS group). The ONS group will receive olanzapine treatment
orally until disease progression. Survival outcomes, including median PFS, OS, and ORR,
will be monitored during treatment through follow-up assessments.
In addition, baseline and post-treatment weight data will be collected to assess the
incidence of weight loss and changes in body mass index (BMI) among patients. Researchers
will collect survey questionnaires and conduct blood analyses to evaluate improvements in
other symptoms associated with olanzapine and changes in quality of life and inflammatory
markers. Primary and secondary study outcomes and adverse events will be assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 years or older;
2. Eastern Cooperative Oncology Group performance status of 0-3;
3. Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer,
hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;
4. Subjected to palliative systemic chemotherapy, regardless of first-line or
second-line treatment;
5. Expected survival ≥ 3 months;
6. The patient is eligible for oral administration without dietary restrictions;
7. Exhibits a favorable adherence to treatment and follow-up, demonstrates compliance
with the research protocol, and willingly signs the informed consent form.
Exclusion Criteria:
1. Weight loss and gain may be attributed to alternative factors, such as edema or
ascites;
2. Suffers from mental disorders or is under the medication of any antipsychotic or
antidepressant drugs;
3. History of central nervous system disorders (such as brain metastasis, epilepsy;
4. Patients undergoing sustained administration of sedative medications or long-term
hormonal therapy, individuals with chronic alcoholism, or those with substance
dependence on medications;
5. Prohibition of Olanzapine Intake for Contraindicated Individuals;
6. History of clozapine-induced agranulocytosis because patients will be at increased
risk for neutropenia with Olanzapine;
7. Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
8. Pregnant and Nursing women;
9. Exclusion criteria include active participation in another interventional clinical
trial, ongoing involvement in an observational (noninterventional) clinical trial,
or being in the survival follow-up phase of an interventional clinical trial;
10. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Qinghai Red Cross Hospital
Address:
City:
Xining
Zip:
810000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiuxia Dong, Dr
Phone:
0971-8267613
Email:
2816278916@qq.com
Start date:
March 20, 2024
Completion date:
March 20, 2028
Lead sponsor:
Agency:
Qinghai Red Cross Hospital
Agency class:
Other
Source:
Qinghai Red Cross Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06338683
