Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

Mahidol University

Status and phase: Enrolling; Phase 3

Conditions: Chemotherapy Induced Nausea and Vomiting

Treatments: Drug: Placebo; Drug: olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT06850454

811/2567(IRB3)

Details and patient eligibility

About

A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

Full description

A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

140 participants in 2 patient groups, including a placebo group

olanzapine

Experimental group

Description:

olanzapine 5 mg on day 1-4

Treatment:

Drug: olanzapine

placebo

Placebo Comparator group

Description:

placebo 5 mg day 1-4

Treatment:

Drug: Placebo