Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Last updated: July 18, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

3

Condition

Anorexia

Treatment

Olanzapine 5 MG

Placebo

Olanzapine 2.5 MG

Clinical Study ID

NCT06517199
980/2566(IRB1)
  • Ages > 18
  • All Genders

Study Summary

Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • pathologically or cytologically metastatic or locally advanced cancer

  • anorexia and >=5% weight loss during the past 6 months or anorexia with numericalscale of anorexia >=5

  • ECOG performance status 0-3

  • able to complete questionaire and able to swallow pills

Exclusion

Exclusion Criteria:

  • receiving chemotherapy or anti-cancer systemic therapy

  • life expectancy longer than 1 month

  • received radiotherapy at head/neck or thoracic or upper abdomen in the past 2 weeks

  • surgery within 4 weeks

  • pregnancy

  • serum bilirubin > 2 mg/dl or serum Cr > 2 mg/dl

  • current use of olanzapine or other antipsychotic drug

  • known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acutecoronary event in the past 6 months

Study Design

Total Participants: 138
Treatment Group(s): 3
Primary Treatment: Olanzapine 5 MG
Phase: 3
Study Start date:
January 22, 2024
Estimated Completion Date:
January 21, 2026

Connect with a study center

  • Division of medical oncology, department of medicine Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital

    Bangkok, 10260
    Thailand

    Active - Recruiting

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