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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo 1 tablet/day for 28 days |
|
| olanzapine 2.5 | Active Comparator | olanzapine 2.5 mg/day for 28 days |
|
| olanzapine 5 | Active Comparator | olanzapine 5 mg/day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine 2.5 MG | Drug | olanzapine 2.5 mg/day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| no greater than 5% weight loss in olanzapine 2.5 mg versus placebo | proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| no greater than 5% weight loss in olanzapine 5 mg versus placebo | proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo | 4 weeks |
| numerical scale of anorexia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin, MD | Contact | +66824194489 | aesi105@yahoo.co.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital | Recruiting | Bangkok | 10260 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19756773 | Background | Navari 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. | |
| 36977285 | Background | Sandhya 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. |
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not yet decided
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Olanzapine 5 MG | Drug | olanzapine 5 mg/day for 28 days |
|
|
| Placebo | Drug | placebo 1 tab/day for 28 days |
|
|
proportion of patients with decreased numerical scale of anorexia
| 4 weeks |
| body weight | body weight change from baseline | week 2 and 4 |
| adverse effects | adverse effects | week 1, 2, 3, 4 |
| Division of medical oncology, department of medicine Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
|
| 34144781 | Background | Arends 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. |
| 32432946 | Background | Roeland 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. |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D013851 | Thinness |
| D006571 | Heterocyclic Compounds |