Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 4: C50- Malignant neoplasm of breast Health Condition 5: C15-C26- Malignant neoplasms of digestive organs
Conditions
Interventions
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 sta
Sponsors
AYUSH Centre of Excellence Ministry of AYUSH
Kasturba Integrative Health Sciences Medical Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Voluntarily signed informed consent. 2.Patients with evaluable disease, histologically documented confirm diagnosis of solid malignancy. 3.Males and females, 18 to 65 years of age (both inclusive). 4.Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 5. Adequate bone marrow reserve (WBC at least 3,000 per mm3, neutrophil count more than or equal to 2000 per mm3, platelet count more than or equal to 1,00,000mm3 and haemoglobin level more than or equal to 8.0 g per dL), renal function (GFR more than equal to 50mL per min), liver function [total bilirubin level less than equal to 2 times upper normal limit (UNL) and serum transaminases levels less than equal to 2.5 times UNL less than equal to 5 times for liver metastasis and or obstructive jaundice. 6. Life expectancy minimum 12 weeks. 7. Patients willing to practice birth control during and for 2 months after treatment. 8. Subjects who have tested negative for HIV, HBsAg and HCV.
Exclusion criteria
Exclusion criteria: 1. Patients who have received prior treatment with docetaxel. 2. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders not adequately controlled with current therapy. 3. Patients with brain metastases or primary CNS malignancies. 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug metabolism. 5. Patients who have received anti-tumor treatments such as radiotherapy, targeted therapy, immunotherapy, and other clinical study drugs within 4 weeks before the first dose of the investigational drug. 6. Traditional medicines/natural product with anti-tumor indications and/or cancer chemotherapy toxicity resolving potential within 4 weeks before the first dose of the investigational drug. 7. Patients who have received corticosteroid (prednisone > 10 mg/day or equivalent) or other immunosuppressive therapies within 4 weeks before the first dose of the investigational drug. 8. Patients who have received any live attenuated vaccine within 4 weeks before the first dose of the investigational drug or planned to receive live attenuated vaccine during the study period. 9. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug, or who need to undergo elective surgery during the immediate subsequent period of the study. 10. Patients who are pregnant or lactating. Note: However as with all concomitant medication usage the study doctors will review on case by-case basis prior to inclusion in trial. The final decision for enrolment will be based on the clinical judgment, discretion of the study doctors. The reason for discontinuation will be noted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures will comprise of treatment emergent grade ââ?°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
| Measure | Time frame |
|---|---|
| Secondary outcome measures will comprise of i) Quality of Life (QoL) assessments ii) Radiological assessments & iii) Hematological & Biochemical assessmentsTimepoint: up to 24 weeks | — |
Countries
India
Contacts
Public ContactDr Vikram Gota
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed