RecruitingPhase 3NCT06517199

Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome


Sponsor

Mahidol University

Enrollment

138 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • pathologically or cytologically metastatic or locally advanced cancer
  • anorexia and >=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia >=5
  • ECOG performance status 0-3
  • able to complete questionaire and able to swallow pills

Exclusion Criteria8

  • 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 acute coronary event in the past 6 months

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Interventions

DRUGOlanzapine 2.5 MG

olanzapine 2.5 mg/day for 28 days

DRUGOlanzapine 5 MG

olanzapine 5 mg/day for 28 days

DRUGPlacebo

placebo 1 tab/day for 28 days


Locations(2)

Faculty of Medicine Siriraj Hospital

Bangkok, Thailand

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, Thailand

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NCT06517199


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