Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer

NCT ID: NCT06338683

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2028-03-20

Brief 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.

Conditions

Advanced Cancer; Olanzapine; Progression Free Survival

Keywords

advanced cancer; olanzapine; chemotherapy; progression free survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (ONS group)

Patients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment.

Group Type: EXPERIMENTAL

Olanzapine 2.5 MG

Intervention Type: DRUG

Oral olanzapine 2.5 mg once daily at bedtime until disease progression

Standard anti-tumor treatment

Intervention Type: DRUG

Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

Nutritional advice

Intervention Type: DIETARY_SUPPLEMENT

All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Arm II (NS group)

No Intervention: Patients received nutritional advice and standard anti-tumor treatment.

Group Type: PLACEBO_COMPARATOR

Standard anti-tumor treatment

Intervention Type: DRUG

Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

Nutritional advice

Intervention Type: DIETARY_SUPPLEMENT

All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Interventions

Olanzapine 2.5 MG

Oral olanzapine 2.5 mg once daily at bedtime until disease progression

Intervention Type: DRUG

Standard anti-tumor treatment

Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

Intervention Type: DRUG

Nutritional advice

All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Intervention Type: DIETARY_SUPPLEMENT

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qinghai Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qinghai Red Cross Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiuxia Dong, Dr

Role: primary

Other Identifiers

QRCH-2024001

Identifier Type: -

Identifier Source: org_study_id