Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Megesterol acetate suspension with Olanzapine: 4 mL of Megesterol acetate suspension thrice daily for 12 weeks with Olanzapine 2.5 mg/day once daily for 12weeks
Control Intervention1: O
Sponsors
All India Institute of Medical Sciences Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed advanced cancer, treated with palliative cytotoxic chemotherapy 2) Eastern cooperative oncology group perfromance status (ECOG PS) of 0 to 3 3) Age 18years and above 4) Patient taking an oral diet 5) Normal renal and hepatic function
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with Carcinoma Breast 2)Patients planned for or on Targeted therapy, or Immunotherapy, or Oral metronomic chemotherapy 3)Patients with concurrent radiotherapy 4)Pregnant or breastfeeding women 5)Persistent and uncontrolled nausea and/or vomiting 6)Active gastrointestinal tract obstruction 7)Patients allergic to the drugs being tested
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare gain in weight in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo 2. To compare improvement in appetite in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the 2 arms: a. Change in quality of life (QOL) b. Degree of nausea c. Rate of completion of chemotherapy d. Side effect profile of the intervention to understand the adverse events due to Megestrol acetate and olanzapine Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactKIRAN YGL
AIIMS BHUBANESWAR
Outcome results
None listed