Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: olanzapine, Placebo.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Nausea and Vomiting. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
Overview
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
Detailed description
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
Interventions
- Drug olanzapine
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4 - Drug Placebo
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Primary outcome measures
- total protection rate of nausea and vomiting [Time frame: 5 days]
Secondary outcome measures (6)
- no nausea rate [Time frame: 5 days]
- severity of nausea and vomiting [Time frame: 5 days]
- adverse events [Time frame: 5 days]
- rescue therapy [Time frame: 5 days]
- quality of life score [Time frame: 5 days]
- Cost [Time frame: 5 days]
Eligibility criteria
Inclusion criteria
- histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
- age of >18 years old
Exclusion criteria
- pregnancy or breast feeding
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Thailand · 1 center
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok
Publications
- 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. PMID 38806870
- 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: 10.11 PMID 34281514
Identifiers
NCT: NCT06850454 · 811/2567(IRB3)