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Recruiting

NCT Number: NCT06850454

Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

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

Recruiting

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Key information

Conditions

Chemotherapy Induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Suthinee Ithimakin, MD

CONTACT

[email protected]

66898127440

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. total protection rate of nausea and vomiting

    Time frame: 5 days

    Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm

Secondary outcomes

  1. no nausea rate

    Time frame: 5 days

  2. severity of nausea and vomiting

    Time frame: 5 days

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

  3. adverse events

    Time frame: 5 days

    Number of patients with other adverse event(s)

  4. rescue therapy

    Time frame: 5 days

    Number of patients requiring additional therapy

  5. quality of life score

    Time frame: 5 days

    EQ-5D-5L score

  6. Cost

    Time frame: 5 days

    medical cost excluding chemotherapy and prophylactic measures

Study contacts

Contact information is provided by the study sponsor or research team.

Suthinee Ithimakin Ithimakin, MD

CONTACT

[email protected]

66898127440

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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