RecruitingPhase 3

Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Thailand138 participantsStarted 2024-01-22

Plain-language summary

Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.

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: * pathologically or cytologically metastatic or locally advanced cancer * anorexia and \>=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia \>=5 * ECOG performance status 0-3 * able to complete questionaire and able to swallow pills Exclusion Criteria: * receiving chemotherapy or anti-cancer systemic therapy * life expectancy longer than 1 month * received radiotherapy at head/neck or thoracic or upper abdomen in the past 2 weeks * surgery within 4 weeks * pregnancy * serum bilirubin \> 2 mg/dl or serum Cr \> 2 mg/dl * current use of olanzapine or other antipsychotic drug * known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acute coronary event in the past 6 months

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

no greater than 5% weight loss in olanzapine 2.5 mg versus placebo

Timeframe: 4 weeks

Trial details

NCT IDNCT06517199

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-21

Contact for this trial

Suthinee Ithimakin, MD

+66824194489 aesi105@yahoo.co.th

View on ClinicalTrials.gov More Anorexia trials