Health Condition 1: null- Non Small Cell Lung Cancer stage III and IV.
Conditions
Interventions
Intervention1: Ayush QOL-2C (Drug)-Dose 2 caps (500mg/cap) twice daily with a glass of water: Two Capsules are to be given twice a day beginning 2 days before start of the first cycle (each cycle cons
Sponsors
Central Council For Research in Ayurveda Siddha under department of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: Age eligible for study 18 years and older Gender eligible for study Both Accept healthy volunteers No Disease characteristics Histological / Cytological confirmed Non Small Cell Lung Cancer Advanced stage III and IV with measurable lesions (Primary/ metastatic lesions) must be evaluable radio graphically. Patient characteristics Over 18 years of age. Performance status Kornoffsky performance status >70% Life expectancy at least 3 months after diagnosis Hepatic Platelets > 100,000/mm3 S. Bilirubin Renal S. Creatinine Other No concurrent active infection, NO prior malignancy. Not pregnant or nursing, effective contraception required for all female patients.
Exclusion criteria
Exclusion criteria: Non measurable disease Known secondary Neoplasm Active Central Nervous System metastasis Hermatolymphoid cancers including acute or chronic leukemia, lymphoma or multiple myeloma Pregnancy or Breastfeeding or adults of reproductive potential not employing effective birth control measures. Concurrent severe or uncontrolled medical disease. Acute or chronic liver disease Confirmed diagnosis of HIV. Insulin dependent diabetes mellitus /abnormal glucose tolerance test (GTT) latent diabetes mellitus type 1 or type Surgery less than 4 weeks prior to entry or not recovered from effects of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To assess the efficacy of â??Ayush QOL-2Câ?? in improvement in quality of life in advanced Non Small Cell Lung Cancer patients receiving Chemotherapy. 2) To assess the safety of â??Ayush QOL-2Câ??Timepoint: 128 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the effect of â??Ayush QOL-2Câ?? on overall survival. 2) To assess the effect of â??Ayush QOL-2Câ?? on event free survival. 3) To assess the effect of â??Ayush QOL-2Câ?? on Progression free survival. Timepoint: nil | — |
Countries
India
Contacts
Public ContactDr Subhash Singh
Bhagwan Mahaveer Cancer Hospital and Research Centre
Outcome results
None listed