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Study of using medicine to boost the appetite in patients with cancer getting treated with chemotherapy

Efficacy of olanzapine along with nutritional advice on reducing anorexia in patients undergoing chemotherapy for gastric, hepato-pancreaticobiliary and lung cancer- A double-blinded randomized-controlled trial(CRAOLA) - CRAOLA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027133
Enrollment
124
Registered
2020-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified Health Condition 2: C23- Malignant neoplasm of gallbladder Health Condition 3: C228- Malignant neoplasm of liver, primary, unspecified as to type Health Condition 4: C259- Malignant neoplasm of pancreas, unspecified Health Condition 5: C169- Malignant neoplasm of stomach, unspecified Health Condition 6: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: olanzapine with nutritional advice: 1.Tab. olanzapine 2.5mg once a day for 12 weeks 2.Nutritional advice in detail which includes type and quantity of diet to be taken and individualiz

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Reseach
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: stage 3 or 4 of Gastric Hepatopancreaticobiliary and lung cancer, who are fit for chemotherapy and are able to take oral diet

Exclusion criteria

Exclusion criteria: a. Patients on adjuvant chemotherapy b. Patients with concurrent radiotherapy c. Intake of olanzapine for more than 4 days per month for any other indications d. On any antipsychotic or antidepressants e. Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks) f. Ascites at time of enrolment g. Pregnancy h. Patients already enrolled in other trails within the past 3 months

Design outcomes

Primary

MeasureTime frame
change in body weight and symptoms of anorexiaTimepoint: At 12 weeks

Secondary

MeasureTime frame
Secondary End Points: Improvement in QoL, FAACT A/CS, VAS Improvement in the skeletal muscle index at third lumbar vertebra Chemotherapy outcomes and toxicityTimepoint: At 12 weeks

Countries

India

Contacts

Public ContactPrasanth Ganesan

Jawaharlal Institute of Postgraduate Medical Education and Research

pg1980@gmail.com04132297312

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 29, 2026