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Enrolling by Invitation

NCT Number: NCT05170919

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Englewood Health

Englewood, New Jersey, 07631, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mirtazapine

Drug

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

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.

Primary outcomes

  1. Weight

    Time frame: 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 outcomes

  1. Quality of Life of patient

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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