NCT05170919

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Englewood Hospital and Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia Nervosa with Significantly Low Body Weight

Interventions

Type	Name	Description
DRUG	Mirtazapine	Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.
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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-12-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study