Chemotherapy Induced Nausea and Vomiting
Conditions
Keywords
olanzapine, moderately emetogenic chemotherapy, carboplatin, irinotecan, oxaliplatin
Brief summary
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
DRUGolanzapine
olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
DRUGPlacebo
placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total protection rate of nausea and vomiting | 5 days | Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of nausea and vomiting | 5 days | Number of patients with grade of nausea or vomiting according to CT-CAE |
| adverse events | 5 days | Number of patients with other adverse event(s) |
| no nausea rate | 5 days | — |
| quality of life score | 5 days | EQ-5D-5L score |
| Cost | 5 days | medical cost excluding chemotherapy and prophylactic measures |
| rescue therapy | 5 days | Number of patients requiring additional therapy |
Countries
Thailand
Contacts
Primary ContactSuthinee Ithimakin Ithimakin, MD
Outcome results
None listed