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Comparing olanzapine with inactive drug for loss of appetite

Olanzapine versus placebo in cancer related anorexia-A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057403
Enrollment
60
Registered
2023-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Tablet Olanzapine 2.5 mg: Tablet Olanzapine 2.5 mg PO (per oral)at night(HS) once daily for 4 weeks Control Intervention1: Tablet Folic acid 5mg: Tablet Folic acid 5 mg PO(per oral) at

Sponsors

Jefrilla Nancy J
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically/cytologically confirmed case of cancer Anorexia in a patient with cancer having VAS score

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy to olanzapine 2. Patients with history of inability to tolerate olanzapine 3. Patients undergoing treatment either with chemotherapy, radiotherapy or surgery within 4 weeks of time before intiation of study 4. Patients on enteral feeding like Nasogastric,nasojejunal,PEG tubes 5. Patient with dysphagia or gastro intestinal obstruction 6. Patient with history of use of Megesterol Acetate/corticosteroids in previous 4 weeks 7. Patients already on statins and or oral/injectable hypoglycemic drugs 8. Patients with a known psychiatric disorder and taking anti psychotics 9. Patient is mentally incapacitated or has a severe emotional or psychiatric disorder, that in the opinion of the study investigator, precludes study entry 10.Patients not consenting for the study

Design outcomes

Primary

MeasureTime frame
To assess the effect of olanzapine on the appetie and compare it with placeboTimepoint: 4 weeks

Secondary

MeasureTime frame
To compare the body weight and BMI of both the study arm To assess other symptoms using R-ESAS in both arms Timepoint: 4 weeks

Countries

India

Contacts

Public ContactDr Kalpana Balakrishnan

Cancer Institute (WIA)

kalpana.balakrishnan@gmail.com9840158777

Outcome results

None listed

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