Health TrialsbyHealthPanel

Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

ConditionChemotherapy Induced Nausea and Vomiting
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin

age of >18 years old

Disqualifiers

pregnancy or breast feeding

has emetic episode within 24 hours

gut obstruction

uncontrolled brain metastasis

Trial design

Design model

Parallel

Treatments tested in this trial

  • olanzapine

    Drug

    olanzapine 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4

  • Placebo

    Drug

    placebo 5 mg oral prior to chemotherapy on day 1 and daily on day 2-4

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: olanzapineExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
5 days

Secondary outcomes

1

no nausea rate

Time frame
5 days
2

severity of nausea and vomiting

Number of patients with grade of nausea or vomiting according to CT-CAE

Time frame
5 days
3

adverse events

Number of patients with other adverse event(s)

Time frame
5 days
4

rescue therapy

Number of patients requiring additional therapy

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov
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