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

Study Overview
=================
Brief Summary
-----------------
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Detailed Description
-----------------
Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.

Official Title
-----------------
An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer

Conditions
-----------------
Anorexia Nervosa With Significantly Low Body Weight

Intervention / Treatment
-----------------
* Drug: Mirtazapine
* Drug: Olanzapine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br> | Drug: Olanzapine<br>* the participant will be prescribed a dosage of 2.5mg per day if > 65 yrs. and 5 mg/per day if <65 yrs. per day. Per physician discretion, participants are allowed a dose escalation of a maximum of 10mg.<br>|
| Experimental: Mirtazapine<br> | Drug: Mirtazapine<br>* Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life of patient | Patients will complete a quality of life (QOL) questionnaire provided at each time point. The higher the score, the worse the outcome. Patients will rate their improvement on a scale from 0 to 4. | 6 months |