A clinical trial to assess the effectiveness of Ayurvedic drugs to reduce toxic effects of chemotherapy and improving Quality of Life of breast cancer patients

INTERVENTION: Intervention1: Suvarna bhasmadi Yoga â?? 395 mg , morning evening, with cowâ??s ghee for 10 months, 2. MauktikyuktaKamadudha â?? 500 mg morning evening, with cowâ??s ghee for 10 months, 3. Padmakadi Ghrut â?? 5 gr., After Lunch and dinner, for 10 months, 4. AnantaVati â?? 1 gr., after lunch and dinner, with water for 10 months : Patients from ICTRC will be in study group and get mentioned Ayurvedic medicines with chemotherapy Intervention2: A Padmakadi Ghrut: 5 gm, After Lunch and dinner, for 10 months Intervention3: A Ananta Vati: 1 gm, after lunch and dinner, with water for 10 months Intervention4: CHEMOTHERAPY/SBD/MKD/PD/AT: Patients will receive Anthracycline and / or Taxane based chemotherapy protocols, post‐surgery with conventional pre medication and post medication. Ayurvedic Medicines ‐ 1.Suvarnabhasmadi Yoga â?? 395 mg , morning evening, with cowâ??s ghee for 10 months, 2. MauktikyuktaKamadudha â?? 500 mg morning evening, with cowâ??s ghee for 10 months, 3. PadmakadiGhrut â?? 5 gr., After Lunch and dinner, for 10 months, 4. AnantaVati â?? 1 gr., after lunch and dinner, with water for 10 months Control Intervention1: CHEMOTHERAPY: Patients will receive Anthracycline and / or Taxane based chemotherapy protocols, post‐surgery with conventional pre medication and post medication . CONDITION: Health condition ‐ Breast Cancer patients undergoing chemotherapy, Problem studied ‐ Adverse effects of chemotherapy PRIMARY OUTCOME: Adverse effects of chemotherapy as per Common Toxicity Criteria (CTC)‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo INCLUSION CRITERIA: Patients who have undergone surgery (either BCS or MRM) with stage I, II and III disease, who are eligible for chemotherapy and who have normal Haemogram, LFT, KFT and 2D Echo SECONDARY OUTCOME: Blood Sugar‐‐‐‐‐‐Timepoint: Day 0(Before 1 chemo) Changes in CA 15.3‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Heamogram‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Immunological Markers Like IL‐1, IL‐6, IL‐8, IL‐10, IFN Gamma, TNF Alpha, CRP‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), , Day84 (Before 5 chemo), , Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Karnofsky score â?? For performance status‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Kidney Function Test‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 63 (Before 4 chemo), Day84 (Before 5 chemo), Day 105 (Before 6 chemo) , Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Liver Function Test‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Oxidative stress by Catalase, SOD, GST,GSTP1 Hypermethylation‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), , Day84 (Before 5 chemo), , Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo Changes in Quality of Life Questionnaires (QLQ C30 and BR 23) of EORTC for Quality of Life ; ‐‐‐‐‐‐Timepoint: Day 0 (Before 1 chemo) , Day 7 (After7th day of 1 chemo), Day 21 (Before 2 chemo), Day 28(After7th day of 2 chemo), Day 42 (Before 3 chemo), Day 49 (After7th day of 3 chemo), Day 63 (Before 4 chemo), Day70 (After7th day of 4 chemo), Day84 (Before 5 chemo), Day 91(After 7th day of 5 chemo), Day 105 (Before 6 chemo) , Day 112 (After7th day of 6 chemo), Day 135 (1 month after last chemo) , 6 months after 1st chemo, 12 months after 1st chemo, 24 months after 1st chemo, 36 months after 1st chemo For assessment of recurrence or metastasis, clinical examination, CT scan (head and neck), X‐ray chest, and other imaging techniques‐‐‐‐‐‐Timepoint: if required