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.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Baskaran Jegadish Siva
Designation
Senior Anaesthetist
Affiliation
Apollo Hospitals, Chennai
Address
Apollo Hospitals, No. 320, Anna Salai, Teynampet, Nandanam,Chennai-600 035 Apollo Hospital, No. 320,
Anna Salai, Teynampet,
Nandanam, Chennai
Chennai
TAMIL NADU
600035
Chennai TAMIL NADU 600035 India
Phone
7299911717
Fax
Email
sivajags@gmail.com
Details of Contact Person Scientific Query
Name
Dr Harleen Kaur
Designation
Research Officer (Homoeo.)
Affiliation
Central Council for Research in Homoeopathy
Address
Central council for Research in Homoeopathy. 61-65 Institutional
Area, Opp. D-Block, Janakpuri.
West
New Delhi DELHI 110058 India
Phone
9818709729
Fax
Email
dr.harleenkaur@gmail.com
Details of Contact Person Public Query
Name
Dr Harleen Kaur
Designation
Research Officer (Homoeo.)
Affiliation
Central Council for Research in Homoeopathy
Address
Central council for Research in Homoeopathy. 61-65 Institutional
Area, Opp. D-Block, Janakpuri.
West
New Delhi DELHI 110058 India
Phone
9818709729
Fax
Email
dr.harleenkaur@gmail.com
Source of Monetary or Material Support
Central Council for Research in Homoeopathy, 61-65 Institutional Area, Opp. D-Block, Janakpuri, 110058, New Delhi
Primary Sponsor
Name
Central Council for Research in Homoeopathy
Address
61-65 Institutional Area, Opp. D-Block, Janakpuri, 110058, New Delhi
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Baskaran Jegadish
Apollo Speciality Hospital
Apollo Speciality Hospital, New No.647, Padma Complex, Anna Salai, Nandanam, Chennai-600035 Tamil Nadu. Chennai TAMIL NADU
7299911717
sivajags@gmail.com
Dr Subramanian Sundaram
VS Hospital
13, East Spurtank Road, Chetpet Chennai-600031 Chennai TAMIL NADU
9444076494
dr.s.subramanian.vsh@gmail.com
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Institutional Ethical Committee-Clinical studies, Apollo Hospital
Approved
Institutional Ethical Committee-VS Hospitals, chennai
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D00-D09||In situ neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Potentised form of cisplatin or docetaxel or paclitaxel or carboplatin or epirubicin or gemcitabine or cyclophosphamide or adriamycin
1C homoeopathic potency of Potentised form of cisplatin or docetaxel or paclitaxel or carboplatin or epirubicin or gemcitabine or cyclophosphamide or adriamycin
Dose-
For single agent- 2.5 ml, four times a day.
For a combination therapy of 2 or 3 drugs, 2.5ml, three times a day.
In case of severe side-effects of chemotherapy drugs as measured on Naranjos ADR scale, frequency may be increased to four times a day.
Mode and duration of administration - oral route, for a period of 7/14/21 days, or as advised by the PI.
Comparator Agent
Standard treatment regimen for chemotherapy (cisplatin, docetaxel, paclitaxel, carboplatin, epirubicin, gemcitabine, cyclophosphamide and adriamycin
Standard treatment regimen for chemotherapy (cisplatin, docetaxel, paclitaxel, carboplatin, epirubicin, gemcitabine, cyclophosphamide or adriamycin) along with placebo resembling homoeopathic medicine regimen.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
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.
1. 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.
2. Non-childbearing or non-child fathering potential and requirement on contraception use.
3. Ability to swallow and retain oral medication.
4. 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.
5. GI diseases or conditions impairing absorptions.
6. Concomitant medication requirements, such as:
No other concurrent medicines or herbal medicines
No recent vaccines or live vaccines during the trial.
ExclusionCriteria
Details
1. Patients who have known allergy or severe side effects of study drugs
2. Primary immunodeficiency and/or other causes of immunosuppression, including HIV or AIDS, autoimmune diseases, and other immuno suppressive disorders.
3. Known or positive hepatitis B or C.
4. History of or current autoimmune disease.
5. Bleeding disorders, active bleeding, or bleeding diathesis.
6. Pregnant or nursing women.
7. Childbearing or child-fathering potential, with almost all trials requiring female and/male contraception use.
8. Psychiatric or mental illness
9. Legal incapacity or social situations limiting compliance.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Primary outcome: 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 (24 weeks) physically or telephonically (in exempted cases where the patient is not in a position to report) or depending on the next chemotherapy session.
Time endpoint:
The outcome will be assessed at the baseline, 2 weeks, 4 weeks,6 weeks, 8 weeks,10 weeks,12 weeks, 14 weeks, 16 weeks,18 weeks,20 weeks,22 weeks,24 weeks and 26 weeks (uptill six months)
Safety endpoints:
1. Any adverse event during study, which does not seem to be attributable to the natural progress of the disease.
2. Any adverse event entering grade 4 and above of CTCAE grading scale during the study.
Secondary Outcome
Outcome
TimePoints
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.
Adherence to chemotherapy at the end of 6th month of the study.
Target Sample Size
Total Sample Size="144" Sample Size from India="144" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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-
· 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.
· 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.
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.
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.