NCT06517199 Olanzapine for Cancer Related Anorexia-cachexia Syndrome
| NCT ID | NCT06517199 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mahidol University |
| Condition | Anorexia |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2026-01-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 138 participants in total. It began in 2024-01-22 with a primary completion date of 2026-01-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06517199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anorexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06517199 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 138 participants.
Is NCT06517199 currently recruiting?
Yes, NCT06517199 is actively recruiting participants. Contact the research team at aesi105@yahoo.co.th for enrollment information.
Where is the NCT06517199 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT06517199 clinical trial?
NCT06517199 is sponsored by Mahidol University. The trial plans to enroll 138 participants.