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A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine | Experimental | olanzapine 5 mg on day 1-4 |
|
| placebo | Placebo Comparator | placebo 5 mg day 1-4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine | Drug | olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| total protection rate of nausea and vomiting | Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| no nausea rate | 5 days | |
| severity of nausea and vomiting | Number of patients with grade of nausea or vomiting according to CT-CAE | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin Ithimakin, MD | Contact | 66898127440 | aesi105@yahoo.co.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38806870 | Background | Shen J, Zhao J, Jin G, Li H, Jiang Y, Wu Y, Gao J, Chen F, Li J, Wang W, Li Q. A prospective randomized controlled clinical trial investigating the efficacy of low-dose olanzapine in preventing nausea and vomiting associated with oxaliplatin-based and irinotecan-based chemotherapy. J Cancer Res Clin Oncol. 2024 May 28;150(5):283. doi: 10.1007/s00432-024-05712-7. | |
| 34281514 |
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IPD will be shared upon request
After study completion and published, lasting for 5 years
The IPD will be provided upon request by email.
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Placebo |
| Drug |
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4 |
|
| adverse events | Number of patients with other adverse event(s) | 5 days |
| rescue therapy | Number of patients requiring additional therapy | 5 days |
| quality of life score | EQ-5D-5L score | 5 days |
| Cost | medical cost excluding chemotherapy and prophylactic measures | 5 days |
| Yamamoto S, Iihara H, Uozumi R, Kawazoe H, Tanaka K, Fujita Y, Abe M, Imai H, Karayama M, Hayasaki Y, Hirose C, Suda T, Nakamura K, Suzuki A, Ohno Y, Morishige KI, Inui N. Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials. BMC Cancer. 2021 Jul 19;21(1):832. doi: 10.1186/s12885-021-08572-3. |
| D006571 | Heterocyclic Compounds |