A clinical trial to evaluate the utility of an extract of Tinospora cordifolia for the prevention of chemotherapy related toxicity in cancer patients

INTERVENTION: Intervention1: Aqueous Standardized Extract of Tinospora cordifolia (AsSET): Tab. AsSET (Tinospora cordifolia extract) 300mg, 2 tablets administered twice a day (1200 mg/day). Intervention will be started on the day of enrollment till the day of completion of last cycle of docetaxel chemotherapy. Control Intervention1: Placebo: Matching placebo administered as 2 tablets twice a day. It will be started on the day of enrollment till the day of completion of last cycle of docetaxel chemotherapy. CONDITION: Health Condition 1: C61‐ Malignant neoplasm of prostate Health Condition 2: C349‐ Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 3: C00‐C14‐ Malignant neoplasms of lip, oral cavity and pharyn X PRIMARY OUTCOME: Primary outcome measures will comprise of treatment emergent grade â?¥2 adverse events (AEs) ; recording, processing & reporting. ; Adverse events assessment: ; Number of Participants with Adverse Events [Time Frame: First dose to study completion (up to 24 weeks). Adverse events (AEs) will be monitored throughout the study and will be graded as ; per the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 ; All undesired symptoms as well as change(s) in vital signs measurements, laboratory evaluations (Biochemistry, hematology and urinalysis), etc. will be reported as adverse events (AEs).Timepoint: up to 24 weeks SECONDARY OUTCOME: Secondary outcome measures will comprise of i) Quality of Life (QoL) assessments ii) ; Radiological assessments & iii) Hematological & Biochemical assessmentsTimepoint: up to 24 weeks INCLUSION CRITERIA: 1. Voluntarily signed informed consent. 2. Patients with evaluable disease, histologically documented confirmed diagnosis of solid malignancy of Head & Neck cancer, Lung cancer, and Prostate cancer. 3. Chemo‐naïve for locally advanced / metastatic disease; recurrent / metastatic squamous cell carcinoma of head & neck (R/M SCCHN), Non‐small cell Lung cancer (NSCLC) and metastatic castration resistant prostate cancer (mCRPC). 4. Males and females, 18 to 65 years of age (both inclusive). 5. ECOG performance status <= 2 [Eastern Cooperative Oncology Group (ECOG) performance status as given in Appendi XD]. 6. Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count >=2000/mm3,platelet count >=1,00,000mm3 and haemoglobin level>= 8.0 g/dL), renal function(GFR>=50mL/min), liver function [total bilirubin level <=2 times upper normal limit (UNL) and serum transaminases levels <=2.5 times UNL/