RecruitingPhase 3NCT06338683

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


Sponsor

Qinghai Red Cross Hospital

Enrollment

230 participants

Start Date

Mar 20, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether olanzapine — a medication typically used for psychiatric conditions but also known to improve appetite — can help patients with advanced stomach, esophageal, liver, pancreatic, bile duct, or lung cancer maintain their weight and survive longer during palliative chemotherapy. **You may be eligible if...** - You are 18 or older - You have stage III or IV inoperable or metastatic cancer of the stomach, esophagus, liver/pancreas/bile ducts, or lung, confirmed by biopsy - You are receiving or will receive palliative chemotherapy - You are expected to live at least 3 months - You can take oral medications without dietary restrictions **You may NOT be eligible if...** - Your weight changes are due to fluid buildup (edema or ascites) - You have a mental health condition or are taking antipsychotic or antidepressant medications - You have brain metastases, epilepsy, or other central nervous system disorders - You use sedatives long-term, are on long-term hormone therapy, or have chronic alcoholism or substance dependence - Olanzapine is medically contraindicated for you - You have a history of low white blood cell counts caused by clozapine - You have uncontrolled diabetes or seizures - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOlanzapine 2.5 MG

Oral olanzapine 2.5 mg once daily at bedtime until disease progression

DRUGStandard anti-tumor treatment

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

DIETARY_SUPPLEMENTNutritional advice

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)

Qinghai Red Cross Hospital

Xining, Qinghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06338683


Related Trials