Efficacy of Megestrol acetate with Olanzapine on anoxia in cancer patients undergoing chemotherapy.

Efficacy of olanzapine combined with megestrol acetate vs olanzapine alone when added to nutritional advice in reducing anorexia in patients undergoing chemotherapy for advanced hepato-pancreato-biliary tract, lung and genitourinary cancer - A randomized double-blind placebo controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079012

Enrollment

146

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: J00-J99- Diseases of the respiratory system Health Condition 3: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: olanzapine combined with megestrol acetate: olanzapine 2.5mg OD combined with megestrol acetate 160mg TDS for 12 weeks Control Intervention1: Olanzapine and Placebo: Olanzapine 2.5mg O

Eligibility

Inclusion criteria

Inclusion criteria: 1. Advanced hepato-pancreato-biliary tract, lung and genitourinary cancer and fit for chemotherapy. 2. Those who were willing to participate (via written consent form) in the study 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 4. Patients taking oral diet

Exclusion criteria

Exclusion criteria: 1. Use of corticosteroids (except pre and post medication of chemotherapy) 2. Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks) 3.Renal and/or hepatic dysfunction (Creatinine clearance = 50ml/min, AST and ALT = 3 times of upper limit of normal value, Total bilirubin = 3mg/dl) 4. On any antipsychotic or antidepressants 5. Patients with concurrent radiotherapy 6. Mechanical obstruction of the gastrointestinal tract 7. Refractory ascites 8. Pregnancy and breast feeding 9. Diabetes mellitus (HbA1c = 8%) 10. Head and neck cancer patients 11. Enrolled in another interventional trial 12. Patient require ryles tube insertion

Design outcomes

Primary

Measure	Time frame
Weight gainTimepoint: 12 weeks	—

Secondary

Measure	Time frame
To compare between the 2 groups: 1. Changes in quality of Life 2. Side effect profile of the intervention (megestrol acetate and olanzapine) and to understand the adverse events 3. Stratification of anorexia in G.I. and other cancer 4. Control of symptoms of anorexia by assessing FAACT-ACS, and VAS score 5. Change in biochemical profile after intervention (albumin, lipid profile and D-dimer)Timepoint: 15 months	—

Measure

Time frame

To compare between the 2 groups: 1. Changes in quality of Life 2. Side effect profile of the intervention (megestrol acetate and olanzapine) and to understand the adverse events 3. Stratification of anorexia in G.I. and other cancer 4. Control of symptoms of anorexia by assessing FAACT-ACS, and VAS score 5. Change in biochemical profile after intervention (albumin, lipid profile and D-dimer)Timepoint: 15 months

—

Countries

India

Contacts

Public ContactDr Ravindra Kumar

Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi

ravindra777ravi@gmail.com9874480045

Outcome results

None listed

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