By InvitationPhase 2

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

United States170 participantsStarted 2022-01-20

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight

Timeframe: 6 months

Trial details

NCT IDNCT05170919

SponsorEnglewood Hospital and Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Anorexia Nervosa with Significantly Low Body Weight trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.