A clinical trial to evaluate the utility of an extract of Tinospora cordifolia for the prevention of chemotherapy related toxicity in cancer patients.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lungHealth Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/08/056129
- Lead Sponsor
- Indian Council of Medical Research (ICMR) Basic Medical Sciences (BMS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 Appendix D].
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/ <=5 times for liver metastasis and/or obstructive jaundice.
7. Life expectancy minimum 12 weeks.
8. Patients willing to practice birth control during and for 2 months after treatment.
9. Subjects who have tested negative for HIV, Haigh and pregnancy.
10. Subjects who have received the vaccination for COVID-19 at least first two doses.
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. COVID vaccination in the preceding 4 weeks or COVID positive by RT-PCR and who have
received any other 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures will comprise of treatment emergent grade â?¥2 adverse events (AEs) <br/ ><br>recording, processing & reporting. <br/ ><br>Adverse events assessment: <br/ ><br>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 <br/ ><br>per the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 <br/ ><br>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 Measures
Name Time Method Secondary outcome measures will comprise of i) Quality of Life (QoL) assessments ii) <br/ ><br>Radiological assessments & iii) Hematological & Biochemical assessmentsTimepoint: up to 24 weeks