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

Sponsor

Englewood Hospital and Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05170919

Collaborator

(none)

170

Enrollment

Location

Arms

22.3

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa With Significantly Low Body Weight	Drug: Mirtazapine Drug: Olanzapine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine	Drug: Olanzapine 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.
Experimental: Mirtazapine	Drug: Mirtazapine Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.

Arm

Intervention/Treatment

Experimental: Olanzapine

Drug: Olanzapine

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.

Experimental: Mirtazapine

Drug: Mirtazapine

Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.

Outcome Measures

Primary Outcome Measures

Weight [6 months]
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.

Secondary Outcome Measures

Quality of Life of patient [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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