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1 Clinical Trial Details (PDF Generation Date :- Sun, 18 Feb :52:56 GMT) CTRI Number Last Modified On 09/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/01/ [Registered on: 12/01/2017] - Trial Registered Retrospectively No Interventional Drug Ayurveda Other A clinical trialon effectiveness of in improving the disease free survival and/or controlling recurrence of disease of breast cancer patients, who are carriers of BRCA 1/2 genes using complimentary Ayurvedic treatment. A Randomized parallel group trial on a cohort on effectiveness of Ayurvedic treatment modalities in improving the disease free survival in carriers of BRCA 1/2 genes inbreast and ovarian cancer patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr S P Sardeshmukh Director, ICTRC, Wagholi, Vishwashantidham, Wagholi,, Maharashtra, INDIA bsdtdadar@gmail.com Details Contact Person (Scientific Query) Dr Swapna Kulkarni Research Assistant, ICTRC, Wagholi, Vishwashantidham, Wagholi,, Maharashtra, INDIA kulkarniswapna@ymail.com Details Contact Person (Public Query) Dr Pradnya Chaugule SRF, ICTRC, Wagholi, Vishwashantidham, Wagholi,, Maharashtra, INDIA Mumbai page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied > Bharatiya Sanskriti Darshan trust > Navajbai Ratan Tata Trust Type of Sponsor List of Countries of Principal Investigator chaugule.pradnya@gmail.com Source of Monetary or Material Support Primary Sponsor Details Dr S P Sardeshmukh VishwashantiDham, Wagholi,,, Maharashtra, INDIA Other [ Director, BSDTs, Integrated Cancer Treatment and Research Centre, Wagholi, ] of Site Site Phone// Dr Rajiv Sarin Cancer Genetics Clinic Cancer Genetics Clinic, Tata Memorial Hospital, Advanced Center for Training Research and Education in Cancer (ACTREC), Rm 305, HBB, 3rd Floor, Mumbai , Mumbai rsarin@actrec.gov.in Dr Vineeta Deshmukh Integrated Cancer Treatment and Research Centre Ground Floor, Integrated Cancer Treatment and Research Centre, VishwashantiDham, Wagholi,, Maharashtra, INDIA ictrcpune@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Advanced Center for Training Research and Education in Cancer (ACTREC) Ethics Committee of Bharatiya Sanskriti Darshan Trust, Status Health Type Patients Submittted/Under Review No Approved 03/02/2015 No Date Condition Health condition Breast and ovarian cancer page 2 / 5

3 Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking patients carriers of BRCA ½ genes. Problem studied Early metastasis and rapid growth of cancer due to inherited susceptibility genes Type Details Comparator Agent Conventional allopathic treatment completed Intervention Age From Age To Gender Details Details SBD/MKD/TC/KK/KH/PANCHA KARMA Year(s) Year(s) Female Permuted block randomization, fixed Inclusion Criteria Morning- Suvarnabhasmadi Yoga 395 mg with cow s ghee, MauktikyuktaKamadudha 500 mg / with milk,evening Trailokyachintamani 125 mg with cow s ghee, MauktikyuktaKamadudha 500 mg / with milk, After lunch and dinner Kumari Kalpa 1 gm, Khadirarishta 10 ml with 50 ml water, Seasonal Panchkarma treatment, Vamana and Basti for year 1 and Basti/Vamana depending upon patient s condition in the 2nd and 3rd year. Local treatment procedure of Shirodhara (rate controlled flow of medicated oil on forehead) with Jatamansi Oil Genetically predisposed patients (BRCA1/2 mutation carriers) with breast or ovarian cancer within 6 months to 1 year of diagnosis. During this period they would have completed conventional cancer treatment.patients with stage I to IV of disease will be included Exclusion Criteria Patients with BRCA1/2 mutation reporting 1 year and more after diagnosis will be excluded Primary Outcome Outcome Timepoints For assessment of recurrence or metastasis, clinical examination, mammography, PET CT, CT scan (Abdomen and pelvis), 2D ECHO, and other imaging techniques Day 0 (Before starting Ayurvedic medicines),after 6 months of Ayurvedic treatment, After 1 year of Ayurvedic medicines,after 1.5 years of Ayurvedic treatment, After 2 years of Ayurvediic medicines, After 2.5 years of Ayurvedic treatment, After 3 yeras of Secondary Outcome Outcome Timepoints Changes in Quality of Life Questionnaires (QLQ C30 and BR23) of EORTC for Quality of Life Changes in Karnofsky score For performance page 3 / 5

4 Target Sample Size status Changes in Heamogram Changes in Liver Function Test Changes in Kidney Function Test Blood Sugar Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details - Brief Summary Changes in Immune parameters (cytokines) like IL 1, IL- 6, IL-8, IL -10, IFN Gamma, TNF Alpha Changes in Oxidative Stress by Catalase, SOD, GST and GSTP1 Hypermethylation Total Sample Size=50 Sample Size from =50 16/03/2016 Years=4 Months=0 Days=0 Open to Recruitment Day 0 ( before starting Ayurvedic treatment) Germ-line mutations are found in 14.1% of patients with breast cancer. About 5% of all breast cancers are hereditary. Majority of these Hereditary Breast Ovarian Cancer (HBOC) syndrome patientshavegermline mutations in BRCA1 or BRCA2 genes.the overall prevalence of BRCA1/2 mutations is estimated to be from 1 in 400 in breast cancers.germline mutations in these genes confer a very high (70-80%) life-time risk for developing breast cancer. BRCA1 is estimated to confer a breast cancer risk of 54% by age 60 years. Breast cancer patients carrying BRCA1/2 mutation have limited life expectancy and limited effectiveness of therapy. They also have a higher risk of developing malignancy in ovary and vice a versa. Breast cancer patients carrying BRCA1/2 mutation also have additional risk of developing quanta lateral malignancy in second breast. Therefore these patients are advised prophylactic surgery to remove ovaries and sometimes breast. Chemoprevention using Tamoxifenor other hormonal treatment offers partial protection from breast cancer but it has its own long-term toxicity. Prophylactic mastectomy and or oopherectomy in patients with BRCA mutation are psychologically stressful to young patients. In general there are several issues of compliance and effectiveness of page 4 / 5

5 Powered by TCPDF ( REF/2016/02/ prophylactic surgery and chemoprevention. This underscores the need for developing and evaluating new strategies with superior efficacy or compliance in preventing or delaying the onset of second malignancy and increasing disease free survival with good physical and mental Quality of life.in this respect Ayurvedic treatment modalities may prove to be helpful in delaying the onset of second malignancy and/or recurrence. In this project, we plan to try Oral AyurvedicMedicinesandPanchakarma treatment for this purpose. Our earlier experience though meagre suggests the effectiveness of adjunct Ayurvedic therapy in these patients. One young patient refused to undergo oopherectomy and opted to take Ayurvedic treatment, completed the treatment for two years and has delivered a healthy baby. Other two patients under Ayurvedic treatment are in complete remission for the last three years. Collaborative clinic Over the last decade the Cancer Genetics Unit of Tata Memorial Centre led by Prof. R. Sarin has established a large cohort of 2000 families with inherited cancer risk.we have been working in collaboration with Dr Sarin by organizing camps and by referring familial cases reporting to our hospital for genetic analysis to Dr Sarin s lab. We would be including those patients who are freshly diagnosed, after confirming their BRCA1/2 status for intervention with Ayurvedic treatment. The results of genetic test will be available in about 3 months period during which time they would have completed conventional therapy. Intervention with Ayurvedic treatment will be started thereafter and continued for 3 years. The choice of Ayurvedic treatment for this project is oral and Panchkarma treatment (twice per year) for three years. To provide a proof of concept, in addition to clinical observations, we would be conducting several laboratory tests to assess the effect of intervention on immune system in terms of status of cytokines and oxidative stress studied using intermediates like SOD, Catalase and GST, and hypermethylation of GSTP1 gene in genetically predisposed patients of breastcance.the results obtained at the end of 3 years will be subjected to statistical analysis. For statistical analysis of a small cohort Kalpan Meier analysis will be used to estimate the rate of disease free survival.the laboratory investigations will be assessed by random effect model. page 5 / 5