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

NCT ID: NCT05170919

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2026-12-31

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.

Conditions

Anorexia Nervosa with Significantly Low Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olanzapine

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

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.

Mirtazapine

Group Type: EXPERIMENTAL

Mirtazapine

Intervention Type: DRUG

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

Interventions

Mirtazapine

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

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Englewood Health

Englewood, New Jersey, United States

Countries

United States

Other Identifiers

E-21-862

Identifier Type: -

Identifier Source: org_study_id