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

NCT05170919 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: E-21-862
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life of patient

  6 months

Study Arms (2)

Olanzapine

EXPERIMENTAL

Drug: Olanzapine

Mirtazapine

EXPERIMENTAL

Drug: Mirtazapine

Interventions

Mirtazapine DRUG

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

Mirtazapine

Olanzapine 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.

Olanzapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Health

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Interventions

Mirtazapine; Olanzapine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 28, 2021
• Study Start: January 20, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)