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To assess the role of olanzapine in improving appetite and health related quality of life in patients with intermediate or locally advanced hepatocellular carcinoma.

Role of olanzapine in improving appetite and health related quality of life in patients with intermediate or locally advanced hepatocellular carcinoma: An open-label randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077603
Enrollment
166
Registered
2024-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Olanzapine plus standard of care: Patients randomized to this group will receive low dose olanzapine (oral tablets, 2.5 mg twice daily for 12 weeks) along with nutritional counseling by

Sponsors

All India Institute of medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with intermediate or locally advanced hepatocellular carcinoma (Barcelona Clinic Liver Cancer [BCLC]- stage B or C).14 2. Patients with underlying cirrhosis of liver (irrespective of Child-Pugh class) 3. Performance status 0-2 as per the Eastern cooperative oncology group (ECOG)15 4. Consenting to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with non-cirrhotic HCC 2. Age less than 18 years or greater than 70 years 3. Presence of any psychiatric comorbidity which would require olanzapine use (e.g. schizophrenia) 4. Patients on any other appetite stimulants (e.g. corticosteroids, megestrol acetate) 5. Patients with ascites which is not controlled on diuretics 6. Patients with uncontrolled diabetes mellitus and hypertension 7. Patients with severe comorbid conditions 8. Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
1.Comparison of change in weight among patients receiving low dose olanzapine plus nutritional counseling as compared to nutritional counseling aloneTimepoint: 12 weeks—

Secondary

MeasureTime frame
1. Comparison of improvement in appetite (assessed using the FAACT-A/CS score and VAS score) among patients receiving low dose olanzapine plus nutritional counseling as compared to nutritional counseling alone 2. Comparison of change in quality of life (assessed using the FACT-Hep score) among patients receiving olanzapine plus nutritional counseling as compared to nutritional counseling alone 3. Comparison of change in sarcopenia (Assessed using the skeletal mass index at the third lumbar vertebra on cross-sectional imaging) among patients receiving olanzapine plus nutritional counseling as compared to nutritional counseling alone 4. Comparison of change in caloric intake among patients receiving olanzapine plus nutritional counseling as compared to nutritional counseling alone 5. Adverse event profile in each study groupTimepoint: 1. 12 weeks 2. 12 weeks 3. 12 weeks 4. 12 weeks 5. 12 weeks—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of Medical Sciences

drshalimar@yahoo.com9868397211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026