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NCT Number: NCT07699276

Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin

A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting

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Key information

Conditions

Cancer (Solid Tumors) Cisplatin Neoplasms Olanzapine 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 2

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Akarin Nimmannit, M.D

SUB_INVESTIGATOR

Sirisopa Techawattanawanna, M.D

PRINCIPAL_INVESTIGATOR

Suthinee Ithimakin

CONTACT

[email protected]

0898127440

Visullaya Sa-nguanwongwan, M.D

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • histologically confirmed solid malignancy
  • scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2

Exclusion criteria

  • pregnancy
  • pelvic or abdominal radiation within 4 weeks
  • uncontrolled brain metastasis
  • other moderate or high emetic risk chemotherapy on day 2-5
  • untreated gut obstruction
  • known allergy or severe adverse effect from palonosetron or olanzapine
  • AST/ ALT > 2.5x or serum creatinine clearance less than 50 ml/min

Treatment and study plan

dexamethasone sparing

Drug

omit dexamethasone on day 2-4

Primary outcomes

  1. complete response rate

    Time frame: 5 days after receiving chemotherapy

    no vomiting and no rescue therapy

Secondary outcomes

  1. no -nausea rate

    Time frame: 5 days after receiving chemotherapy

    no nausea symptom

  2. degree of nausea vomiting

    Time frame: 5 days after receiving chemotherapy

    grading of nausea vomiting

  3. adverse effects

    Time frame: 5 days after receiving chemotherapy

    adverse effects

  4. rescue therapy

    Time frame: 5 days after chemotherapy

    additional treatment for nausea or vomiting

Study contacts

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

Suthinee Ithimakin

CONTACT

[email protected]

+66898127440

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

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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