Using Olanzapine to Treat Cancer-Related Appetite Loss
Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
This study is testing if the medication olanzapine can help people with advanced cancer who have lost their appetite and weight feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Trial ID | NCT06517199 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of olanzapine in reducing symptoms of anorexia-cachexia syndrome in patients with advanced cancer who are not undergoing chemotherapy. Participants will be randomly assigned to receive either olanzapine at doses of 2.5 mg or 5 mg, or a placebo. The study aims to assess changes in appetite and weight loss over the treatment period. It targets patients who have experienced significant weight loss and anorexia due to their cancer condition.
Who should consider this trial
Good fit: Ideal candidates include patients with metastatic or locally advanced cancer experiencing significant weight loss and anorexia.
Not a fit: Patients currently receiving chemotherapy or those with a life expectancy of more than one month may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve appetite and quality of life for cancer patients suffering from anorexia-cachexia syndrome.
How similar studies have performed: Previous studies have shown olanzapine to be effective in reducing chemotherapy-induced anorexia, but this specific application in non-chemotherapy patients is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok and 1 other locations
- Faculty of Medicine Siriraj Hospital — Bangkok, Thailand (Recruiting)
- Division of medical oncology, department of medicine Siriraj Hospital — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Suthinee Ithimakin, MD
- Email: aesi105@yahoo.co.th
- Phone: +66824194489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.