Health Condition 1: C34- Malignant neoplasm of bronchus andlung
Conditions
Interventions
None listed
Sponsors
Ministry of Ayush
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are ready to provide written informed consent and willingness and ability to comply with study protocol. 2. Newly diagnosed patients of metastatic (Stage 4) Non-Small Cell Lung Cancer (NSCLC)with histological confirmation, as per tissue biopsy. 3. Age group 18 â?? 65 yrs irrespective of sex and religion. 4. Epidermal growth factor receptor (EGFR)mutation negative, on EGFR mutation analysis 5. Patients with PD-L1expression level 6. Patients having an Eastern Cooperative Oncology Group (ECOG) performance score not higher than 2.
Exclusion criteria
Exclusion criteria: 1. Patients with primary immunodeficiency and/or other causes of immunosuppression, including HIV or AIDS, autoimmune diseases, and other immunosuppressive disorders 2. Patients with known or active HIV or AIDS 3. Patients with known allergies or sensitivity to the study drug or components 4. Patients with current cardiovascular disease and/or risk factors, such as angina pectoris, uncontrolled hypertension, myocardial infarction, congestive heart failure, stroke, or cardiac arrhythmia or having a history of the same in past 6 months. 5. Patients with poorly controlled Hypertension ( >160/100 mm of Hg) 6. Pregnant or nursing women 7. Patients with other current malignancy 8. Patients with current or history of drug or substance abuse 9. Patients with psychiatric or mental illness 10. Any medical conditions that, in the opinion of the investigator would interfere with the outcome of the study. 11. Patients participating in any other interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Assessment of quality of life by using oEastern Cooperative Oncology Group (ECOG) performance status â?? Malayalam Version oKarnofsky Performance Status Scale oEuropean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 ( EORTC QLQ-C30) â??Malayalam Version oEuropean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire â??Lung Cancer 29 (EORTC QLQ â?? LC13) â?? Malayalam Version Timepoint: Assessments will be done on 0th day 30th day 60th day 90th day 120th day 150th day 180th day | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Assessment of clinical symptoms a. Fatigue â?? Visual Analogue Fatigue Scale (VAFS) b. Loss of appetite - (Hunger Visual Analogue Scale) c. Shortness of breath â?? modified Medical Research Council Dyspnea Scale (mMRC) d. Cough â?? Cough Visual Analogue Scale e. Pain â?? Pain Visual Analogue Scale f. Blood in sputum (hemoptysis) Timepoint: Assessments will be done on 0th day 30th day 60th day 90th day 120th day 150th day 180th day | — |
Countries
India
Contacts
Public ContactDr Mahesh K
Arya Vaidya Sala Kottakkal
Outcome results
None listed