Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Phase 3

Recruiting

• Conditions: Cachexia; Anorexia
• Interventions: Drug: Placebo; Drug: Olanzapine 2.5 MG; Drug: Olanzapine 5 MG

• Registration Number: NCT06517199
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24
• Primary Completion: 2026-01-21
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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 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 acute coronary event in the past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo 1 tablet/day for 28 days
olanzapine 2.5	Olanzapine 2.5 MG	olanzapine 2.5 mg/day for 28 days
olanzapine 5	Olanzapine 5 MG	olanzapine 5 mg/day for 28 days

Primary Outcome Measures

Name	Time	Method
no greater than 5% weight loss in olanzapine 2.5 mg versus placebo	4 weeks	proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo

Secondary Outcome Measures

Name	Time	Method
numerical scale of anorexia	4 weeks	proportion of patients with decreased numerical scale of anorexia
adverse effects	week 1, 2, 3, 4	adverse effects
no greater than 5% weight loss in olanzapine 5 mg versus placebo	4 weeks	proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo
body weight	week 2 and 4	body weight change from baseline

Trial Locations

Locations (2)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Division of medical oncology, department of medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand