Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy
NCT ID: NCT06850454
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2025-01-10
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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olanzapine
olanzapine 5 mg on day 1-4
olanzapine
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
placebo
placebo 5 mg day 1-4
Placebo
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Interventions
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olanzapine
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Placebo
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Eligibility Criteria
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Inclusion Criteria
* age of \>18 years old
Exclusion Criteria
* has emetic episode within 24 hours
* gut obstruction
* uncontrolled brain metastasis
* allergy to or current use of olanzapine
* concomittant moderate or high emetogenic chemotherapy on day 2-5
* Total bilirubin \> 2 mg/dl or creatinine clearance \< 30 ml/min
* unable to swallow drug
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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suthinee ithimakin
Associate professor
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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811/2567(IRB3)
Identifier Type: -
Identifier Source: org_study_id
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