A multicentric, double-blind, randomized, placebo-controlled, phase III study to evaluate the role of potentized (Tautopathy) form of chemotherapy in patients to determine the reduction in the pre-identified side effects of non-potentised chemotherapy drugs cisplatin, docetaxel, paclitaxel, carboplatin, epirubicin, gemcitabine, cyclophosphamide and adriamycin on cancer patients to enhance tolerance to chemotherapy regimen.

Title: A multicentric, double-blind, randomized, placebo-controlled, phase III study to evaluate the role of potentized (Tautopathy) form of chemotherapy in patients to determine the reduction in the pre-identified side effects of non-potentised chemotherapy drugs Cisplatin, Docetaxel, Paclitaxel, Carboplatin, Epirubicin, Gemcitabine, Cyclophosphamide and Adriamycin on cancer patients to enhance tolerance to chemotherapy regimen.

|Item

Response

| --- | --- | |PI / Co-PI credential

Protocol development team

 ·   Principal Investigator-

Dr. Baskaran Jegadish, Senior Anaesthetist,  Apollo Hospitals, Chennai

·   Co-Principal Investigator and Trial Co-     Ordinator-

Dr. Harleen Kaur, Research Officer (H)/S-2, CCRH

·  Mentor-

Dr. Subhash Kaushik, Director General, CCRH

·  Site- Co-Investigators (Apollo Hospitals,     Chennai)-

Dr. S.G. Ramanan, Senior medical  oncologist, Apollo Cancer Centre, Nandanam, Chennai

Dr. Selvi Radhakrishnan, Senior Oncologist Breast Surgeon, Apollo Hospitals, Chennai

Dr N. Ragavan, Senior Urologist, UroOncologist & Robotic Surgeon, Apollo Hospitals, Chennai

·     Site- Co-Investigator (VS Hospital, Chennai)-

Dr. Subramanian Sundaram, HOD, Sr. Medical Oncologist Founder Chairman & Managing Director, VS      Hospital, Chennai

·     Protocol Development advisor-

Dr. Saravanan Natarajan, CCRH

·     Protocol Development Team-

Dr. D. Karthikeyan, Research Officer (H)/S-2,  CCRH

Dr. Shalini Rao, Research Associate (H), CCRH

Dr. Annie Valentina M.I, Research Associate (H), CCRH

|Duration of service period remaining

None of the Investigators are superannuating during the study period.

|Institute credential

 ·   CCRH, New Delhi

·   Apollo Hospitals, Chennai

·   VS Hospital, Chennai

|Phase

III

|Methodology

Randomized placebo-controlled trial

|Study duration

2 years

(Enrolment- 1 Year, Follow-up- 6 months, Data analysis and manuscript writing- 6 months)

|Primary objective

To determine the reduction in the pre-identified side effects of non-potentised chemotherapy drugs                  cisplatin, docetaxel, paclitaxel, carboplatin, epirubicin, gemcitabine, cyclophosphamide and adriamycin          on cancer patients through CTCAE version 5 and Naranjo ADR probability scale.

                                               |Secondary objectives

To study the effectiveness of potentised form of widely used chemotherapy drugs, cisplatin, docetaxel,            paclitaxel, carboplatin, epirubicin, gemcitabine, cyclophosphamide and adriamycin in cancer patients to          enhance tolerance to chemotherapy regimen.

|Number of subjects

144 (72 in each arm)

|Inclusion criteria

·   Newly diagnosed cases of any type of carcinoma recommended to initiate chemotherapy with cisplatin or        docetaxel or paclitaxel or carboplatin or epirubicin or gemcitabine or cyclophosphamide or adriamycin or         any of the above combination in regimen.

·  18 years or any gender advised chemotherapy with any of the above-mentioned chemotherapy agents in         regimen and willing to give written informed consent for participation.

·   Non-childbearing or non-child fathering potential and requirement on contraception use.

·   Ability to swallow and retain oral medication.

·   History of or current cardiovascular disease and/or risk factors, such as angina pectoris, uncontrolled           hypertension, myocardial   infarction, congestive heart failure, stroke, or cardiac arrhythmia.

·   GI diseases or conditions impairing absorptions.

·   Concomitant medication requirements, such  as:

1. No other concurrent medicines or herbal  medicines

2. No recent vaccines or live vaccines during the trial.

|Exclusion criteria

·   Patients who have known allergy or severe side effects of study drugs

·   Primary immunodeficiency and/or other causes of immunosuppression, including HIV or AIDS,                       autoimmune diseases, and other immuno suppressive disorders.

·    Known or positive hepatitis B or C.

·    History of or current autoimmune disease.

·    Bleeding disorders, active bleeding, or bleeding diathesis.

·    Pregnant or nursing women.

·    Childbearing or child-fathering potential, with almost all trials requiring female and/male contraception            use.

·    Psychiatric or mental illness

·    Legal incapacity or social situations limiting compliance.

|Study product, dose, route

Potentised drugs, twice daily, oral route. For single agent- 2.5 ml four times a day. For a combination             therapy of 2 or 3 agents, 2.5ml, three times a day.    In case of severe ADR, frequency may                           be increased      to four times a day.

|Duration of administration

6 months

|Primary outcomes

Change in CTCAE 5 grading and Naranjo ADR score of various components of ADR every 2 weeks, till          the end of the study i.e., 6 months (26weeks) physically or telephonically (in exempted cases where the        patient is not in a position to report) or depending on the next chemotherapy session.

|Secondary outcomes

Adherence to chemotherapy scale, as prescribed by consulting oncologist for at least six months, or for        the entire duration of chemotherapy as planned, whichever is earlier.