Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Addition of Olanzapine: Olanzapine 2.5 mg orally once daily with Morphine for dyspnea for 28-days
Control Intervention1: Addition of placebo: Matching placebo tablet orally once daily w
Sponsors
Conquer Cancer the ASCO Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 years and weight more than 40 kg. Diagnosis of Histologically or cytologically confirmed lung cancer Dyspnea Severity of Modified Medical Research Council Dyspnea Scale (mMRC) more than 2 on a 0 to 4 scale at screening. Performance Status ECOG 0 to 3. Life Expectancy more than 8 weeks, as assessed by the investigator. Written informed consent obtained. Adequate contraception for participants of reproductive age. Patient not on active oncology treatment. Female patients in the fertility period will be tested for pregnancy.
Exclusion criteria
Exclusion criteria: Respiratory Conditions Acute respiratory failure requiring mechanical ventilation, severe COPD ,FEV1 less than 30 percent predicted, active pneumonia, or respiratory infection. Cardiac Conditions Recent myocardial infarction within 3 months, uncontrolled heart failure NYHA Class IV, and QTc greater than 480 msec. Neurological or Psychiatric Active delirium or severe cognitive impairment, history of neuroleptic malignant syndrome, and current antipsychotic medication use. Drug related Known hypersensitivity to morphine or olanzapine, current opioid use greater than 30 mg morphine equivalent daily, monoamine oxidase inhibitor use within 14 days. Laboratory Severe hepatic impairment Child-Pugh Class C and severe renal impairment CrCl less than 30 mL per min. Other Pregnancy or breastfeeding, participation in other interventional studies. Patients receiving antipsychotics or MAO inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of adding olanzapine to morphine compared to morphine alone in reducing dyspnea intensity from baseline to day 28, measured using NRS in patients with lung cancerTimepoint: baseline, 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of combination therapy (olanzapine + morphine) by monitoring adverse events and respiratory function. To do functional assessments of patients using the activities of daily living scale, Cancer Dyspnea Scale scores, and time to clinically meaningful improvement in the two groups. To assess the quality of life using the EORTC QLQ-C30 and Palliative Performance Scale scores at various time points. To assess healthcare utilization in terms of rescue medication use, emergency visits, and hospitalizations. To assess caregiver burden in the two groups using the Zarit Burden Interview-12 (ZBI-12) and caregiver satisfaction. Timepoint: baseline, 28 days | — |
Countries
India
Contacts
Public ContactDr Nishkarsh Gupta
All India Institute of Medical Sciences
Outcome results
None listed