Effect of sublingual orally disintegrating tablet (ODT) olanzapine for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV)

The Comparison Between Sublingual Administration Of Orally Disintegrating Olanzapine Versus Intravenous Administration Of Metoclopramide For Treatment Of Breakthrough Chemotherapy-Induced Nausea And Vomiting (CINV) In Patients Receiving Chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251008001

Enrollment

164

Registered

2025-10-08

Start date

2025-09-21

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cancer receiving highly or moderately emetogenic chemotherapy who develop breakthrough chemotherapy-induced nausea and vomiting (CINV) despite standard antiemetic prophylaxis. Breakthrough chemotherapy induced nausea and vomiting, Olanzapine ODT

Interventions

Sublingual ODT olanzapine 5 mg will be given within 30 minutes after experiencing any emesis or moderate to severe nausea as defined by greater than 3 on the MDASI scale of 0 to 10.,In control group,

Experimental Drug,Active Comparator Drug

sublingual olanzapine ODT,intravenous metoclopramide 10 mg

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 80 years old 2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status scale 0-1 3. Patients with any type and stage of cancer who are receiving highly or moderately emetogenic chemotherapy, in any treatment cycle. 4. Fully conscious patients with the ability to write a consent form 5. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Patients who have previous nausea/vomiting 24 hours before the beginning of chemotherapy 2. Patients who are allergic to metoclopramide or olanzapine 3. Patients who have uncontrolled psychiatric disease or use antipsychotic drugs for 30 days prior to or during protocol therapy 4. Patients who have severe cognitive compromise and a known history of CNS disease (e.g. brain metastasis, seizure disorder) 5. Patients who are pregnant 6. Patients who are in the breastfeeding process 7. Patients who have previously participated in this study

Design outcomes

Primary

Measure	Time frame
no nausea 1 hr after starting intervention number of patients	—

Secondary

Measure	Time frame
no emesis 1 hr after starting intervention number of patients,no nausea 4 hr after starting intervention number of patients,no emesis 4 hr after starting intervention number of patients,crossover during hospitalization number of patients,adverse events during hospitalization incidence,difference of nausea score (MDASI scale) 1 and 4 hr after starting intervention questionnaire	—

Countries

Thailand

Contacts

Public ContactSinarak Srithongchai

Chulalongkorn University

sinarakjan@gmail.com668274235

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026