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

Phase 2

• Conditions: Anorexia Nervosa with Significantly Low Body Weight
• Interventions: Drug: Mirtazapine; Drug: Olanzapine

• Registration Number: NCT05170919
• Lead Sponsor: Englewood Hospital and Medical Center

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-28
• Study Start: 2022-01-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirtazapine	Mirtazapine	-
Olanzapine	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Englewood Health; 🇺🇸 Englewood, New Jersey, United States