Clinical trial · Interventional
Olanzapine for Cancer Related Anorexia-cachexia Syndrome
Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
NCT06517199CI-TRIAL-00079073unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine 2.5 MG | Drug | — | UNRESOLVED |
| Olanzapine 5 MG | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo 1 tablet/day for 28 days
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- olanzapine 2.5
- description
- olanzapine 2.5 mg/day for 28 days
- interventionNames
- Drug: Olanzapine 2.5 MG
- type
- ACTIVE_COMPARATOR
- label
- olanzapine 5
- description
- olanzapine 5 mg/day for 28 days
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDNavari RM, Brenner MC. Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. Support Care Cancer. 2010 Aug;18(8):951-6. doi: 10.1007/s00520-009-0739-7. Epub 2009 Sep 11. PMID 19756773
- BACKGROUNDSandhya L, Devi Sreenivasan N, Goenka L, Dubashi B, Kayal S, Solaiappan M, Govindarajalou R, Kt H, Ganesan P. Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. J Clin Oncol. 2023 May 10;41(14):2617-2627. doi: 10.1200/JCO.22.01997. Epub 2023 Mar 28. PMID 36977285
- BACKGROUNDArends J, Strasser F, Gonella S, Solheim TS, Madeddu C, Ravasco P, Buonaccorso L, de van der Schueren MAE, Baldwin C, Chasen M, Ripamonti CI; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines☆. ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092. PMID 34144781
- BACKGROUNDRoeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20. PMID 32432946