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

Last updated: September 9, 2024
Sponsor: Englewood Hospital and Medical Center
Overall Status: Active - Enrolling

Phase

2

Condition

Weight Loss

Anorexia

Vomiting

Treatment

Olanzapine

Mirtazapine

Clinical Study ID

NCT05170919
E-21-862
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 3-6months, not explained by simple starvationo Simple starvation is considered to be excluded when weight loss is notameliorated 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 phoneand written logs

  • Patients on Dexamethasone will be allowed

Exclusion

Exclusion Criteria:

  • • Abnormal liver function defined as > twice upper limit of normal

  • Elevated QTco EKG performed within 1 year of enrollment will be accepted

  • Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of theirprimary source of daily calorie intake

  • Taking Marinol within 2 week of enrollment onto study

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Olanzapine
Phase: 2
Study Start date:
January 20, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Englewood Health

    Englewood, New Jersey 07631
    United States

    Site Not Available

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