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A Study Comparing Two Medicines, Olanzapine and Mirtazapine, for Improving Appetite and Weight in Patients with Advanced Cancer

Comparison of Olanzapine and Mirtazapine on Cancer Associated Anorexia and Cachexia Syndrome in Advanced Cancer Patients: An Open Label, Prospective, Comparative, Interventional Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097352
Enrollment
140
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: R634- Abnormal weight loss Health Condition 2: R630- Anorexia

Interventions

Intervention1: Olanzapine: 5mg per day HS FOR 28 days Control Intervention1: Mirtazapine: 15mg per day HS for 28 days

Sponsors

Arun Kumar Garg
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above. 2. Registered in the palliative care centre. 3. Suffering from histologically diagnosed advanced cancer (Cancer with metastasis). 4. Patients with a weight loss of more than 5 percent of body weight over the past 6 months or loss of 2-5 percent of body weight over the past 6 months plus Body Mass Index (BMI) of less than 20. 5. Loss of appetite score (SNAQ score less than 14). 6. Patient giving written informed consent for this Study.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating female. 2. Known history of hypersensitivity to study drugs. 3. Severe renal impairment (creatinine more than 2). 4. Severe liver impairment (Child Pugh score more than 10). 5. Significant disorder of bone marrow. 6. Severe cardiac impairment. 7. Patient taking antipsychotic, sedative psychotropic drug, atropine, and its substitute. 8. Non cooperative patient.

Design outcomes

Primary

MeasureTime frame
Mean change in body weight of the patients from baseline to the 2nd and 4th weeks after starting treatment.Timepoint: At the 2nd and 4th weeks after starting treatment

Secondary

MeasureTime frame
Change in HADS (Hospital Anxiety and Depression Scale) scoresTimepoint: At the 2nd and 4th weeks after starting treatment;Change in LSEQ (Leeds Sleep Evaluation Questionnaire) scoresTimepoint: At the 2nd and 4th weeks after starting treatment;Change in VAS (Visual Analogue Scale) scores for nausea and vomitingTimepoint: At the 2nd and 4th weeks after starting treatment

Countries

India

Contacts

Public ContactDr Deepak Kumar Garg

JLN Medical College, Ajmer

drdeepakgarg04@gmail.com9829399322

Outcome results

None listed

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