NCT06850454

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 27, 2025

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 7, 2024

Last Update Submit

February 21, 2025

Conditions

Chemotherapy Induced Nausea and Vomiting

Keywords

olanzapinemoderately emetogenic chemotherapycarboplatinirinotecanoxaliplatin

Outcome Measures

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

    5 days

Secondary Outcomes (6)

  • no nausea rate

    5 days

  • severity of nausea and vomiting

    5 days

  • adverse events

    5 days

  • rescue therapy

    5 days

  • quality of life score

    5 days

  • +1 more secondary outcomes

Study Arms (2)

olanzapine

EXPERIMENTAL

olanzapine 5 mg on day 1-4

Drug: olanzapine

placebo

PLACEBO COMPARATOR

placebo 5 mg day 1-4

Drug: Placebo

Interventions

olanzapineDRUG

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

olanzapine
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
  • age of \>18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Publications (2)

  • 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: 38806870BACKGROUND

  • 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: 10.1186/s12885-021-08572-3.

    PMID: 34281514BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Suthinee Ithimakin Ithimakin, MD

CONTACT

66898127440aesi105@yahoo.co.th

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 7, 2024

First Posted

February 27, 2025

Study Start

January 10, 2025

Primary Completion

January 10, 2026

Study Completion

January 31, 2026

Last Updated

February 27, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

IPD will be shared upon request

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After study completion and published, lasting for 5 years
Access Criteria
The IPD will be provided upon request by email.

Locations

TH(1)