Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Gefitinib (morning): 250 mg per oral once daily for 3 months
Control Intervention1: Gefitinib (evening): 250 mg per oral once daily for 3 months
Sponsors
Tavneet Kaur Makkar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age >18 years irrespective of gender 2) Pathology confirmed NSCLC patients 3) EGFR sensitized mutation 4) Patients being planned to be started on gefitinib as a first line /maintenance /second line agent.
Exclusion criteria
Exclusion criteria: 1) Patients not willing to participate in the study. 2) Patients on systemic steroids. 3) Patients in active uncontrolled pain/ severe distress not controlled on optimal analgesia. 4) Patients reporting disturbed sleep-wake cycle in last 7 days. 5) Patients with ECOG performance status >3 6) Known case of hepatic cirrhosis 7) Patients taking strong CYP3A4 inducers and inhibitors like rifampicin/ phenytoin/ ketoconazole/ itraconazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood level of gefitinib after morning versus evening administrationTimepoint: 0,15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum EGFR with gefitinib treatmentTimepoint: 0, 3 months;Correlation of response to treatment with blood levels of gefitinib.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Pooja Gupta
All India Institute of Medical Sciences
Outcome results
None listed