Health Condition 1: D00-D09- In situ neoplasms
Conditions
Interventions
Intervention1: 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 cisp
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
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. 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: Adherence to chemotherapy at the end of 6th month of the study. | — |
Countries
India
Contacts
Public ContactDr Harleen Kaur
Central Council for Research in Homoeopathy
Outcome results
None listed