Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer

• Status: Enrolling by invitation
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Englewood Hospital and Medical Center
• Treatments: Mirtazapine; Olanzapine

Criteria

Inclusion Criteria:

• • 18 years of age or older

• Able to provide informed consent

• Pathologically and/or clinically confirmed diagnosis of advanced cancer

• At any point of treatment with standard chemotherapy*

o Scheduled to start, have discontinued or completed, or currently receiving

• Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation

o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).

• Life expectancy of at least 4 months

• Able to communicate well and comply with study requirements, including by phone and written logs

• Patients on Dexamethasone will be allowed

Exclusion Criteria:

• • Abnormal liver function defined as > twice upper limit of normal

• Elevated QTc

o EKG performed within 1 year of enrollment will be accepted

• Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of their primary source of daily calorie intake

• Taking Marinol within 2 week of enrollment onto study