Study of Olanzapine for Appetite Loss and Weight Gain in Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal, or Lung Cancer

What this Trial Is About

Researchers are evaluating the use of olanzapine for managing appetite loss in patients with advanced or metastatic esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer. This phase II trial focuses on patients experiencing cancer cachexia, a syndrome causing weight and muscle loss, weakness, and fatigue, while they receive non-curative cancer therapy. Olanzapine targets key brain chemicals that may stimulate appetite, help restore calorie intake, reduce weight loss, and improve quality of life. Participants are randomly assigned to one of three groups a low dose 2.5 mg of olanzapine, a higher dose 5 mg of olanzapine, or a placebo. Each treatment is taken orally each night for 12 weeks if tolerated, with an option to continue the lower dose for an additional 12 weeks. Optional CT scans and monthly blood samples may be collected during the study. After treatment, participants are followed up one week later. During the study, participants will complete questionnaires and undergo assessments including weight monitoring, appetite evaluation, nutritional status, physical function, patient-reported symptoms, and quality of life measures. Safety and side effects are monitored throughout. Researchers aim to measure how many patients gain more than 5% of their weight over 12 weeks. Hospitalizations and emergency visits are also tracked. The total study duration is up to 24 weeks of treatment plus follow-up.

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer