An Open-label,two-arm, Exploratory Randomised Controlled Trial to evaluate the effect of Vardhamana Pippali Rasayana as an add-on therapy in the management of Non-small cell lung cancer
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- -Objective Response Rate assessed through changes in the PET CT scan reports prior to & after intervention according to PET Response Criteria in Solid Tumors (PERCIST,Version 1.0).
Study Overview
Brief Summary
Lung cancer, with increasing incidence and disproportionatelyhigh mortality remains a major health hazard to the Indian population. Majorityof the patients present at the advanced stages of the disease with narrowcurative options. Majority belong to the low socio-economic strata of thesociety and hence unable to reap the benefits of advanced therapeutictechniques and biologics. With disease progression occurring less than a yearpost-diagnosis, there is need for urgent intervention that is effective as wellas economically feasible. Quality of life is an important clinical indicator ofdisease control for the patient.
Traditional systems of medicine like Ayurveda are soughtafter by the cancer patients for reduced side-effect profile and improvedquality of life. Dhehghan et al reported a significantly high QoL among CAMusing terminally ill cancer patients.The study drug, Vardhamana Pippali Rasayana is widely practiced in treating thesymptoms of cough, dyspnea and anorexia among lung cancer patients to goodresults. However, there are no clinical evidences generated so far. This study is expected to improve the treatment outcomes of lungcancer in terms of symptomatic relief and enhance quality of life of thepatient without causing major side-effects. Moreover, based on the previousin-vitro and in-vivo studies, there may be better tumor response to the add-onintervention.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
Inclusion Criteria
- •1.Patients of histologically proven lung malignancy (NSCLC of any subtype), willing to participate in the study 2.Patients with ECOG PS 0-III 3.Patients suffering from non-small cell lung cancer- Stage I to IV B and treatment naïve at the time of screening 4.Age- 18-75 years of age 5.Gender- both male and female (non-pregnant, non-lactating) 6.Patients with no diagnosis of cancer within the past one year.
Exclusion Criteria
- •Patients not willing to take part in the study.
- •Unable to take oral medications especially in the form of powder.
- •Patients of ECOG PS IV, V.
- •Patients with active peptic ulcer, dyspepsia, or bleeding per rectum.
- •Significant cardiovascular disease, such as myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina. -Inability to comply with other requirements of the protocol.
Outcomes
Primary Outcomes
-Objective Response Rate assessed through changes in the PET CT scan reports prior to & after intervention according to PET Response Criteria in Solid Tumors (PERCIST,Version 1.0).
Time Frame: WEEK-1 WEEK 4 WEEK8 WEEK 12 | WEEK 16 WEEK 20 WEEK 24 | WEEK 28
-Changes in the clinical symptoms of the patients before & after treatment using EORTC- LC13 questionnaire.
Time Frame: WEEK-1 WEEK 4 WEEK8 WEEK 12 | WEEK 16 WEEK 20 WEEK 24 | WEEK 28
Secondary Outcomes
- -Changes in the Quality of Life of the patients before & after treatment using EORTC-QLQ- C30 questionnaire.(-Changes in the lung functions by means of Spirometry.)