Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06517199

Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Led by Mahidol University · Updated on 2024-07-24

138

Participants Needed

2

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically or cytologically confirmed metastatic or locally advanced cancer
  • Anorexia with at least 5% weight loss in the past 6 months or anorexia with a numerical scale score of 5 or higher
  • ECOG performance status of 0 to 3
  • Ability to complete questionnaires and swallow pills
Not Eligible

You will not qualify if you...

  • Currently receiving chemotherapy or anti-cancer systemic therapy
  • Life expectancy longer than 1 month
  • Radiotherapy to head/neck, thoracic, or upper abdomen within the past 2 weeks
  • Surgery within the past 4 weeks
  • Pregnancy
  • Serum bilirubin greater than 2 mg/dl or serum creatinine greater than 2 mg/dl
  • Current use of olanzapine or other antipsychotic drugs
  • Known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure, or acute coronary event within the past 6 months

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Faculty of Medicine Siriraj Hospital

Bangkok, Thailand, 10260

Actively Recruiting

2

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, Thailand, 10700

Actively Recruiting

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Research Team

S

Suthinee Ithimakin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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