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CTRI Number  CTRI/2025/08/093448 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Integrative therapy ]  
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Oncothermia, Vitamin C based integrative oncology therapies on female breast cancer patients 
Scientific Title of Study   Metabolic response of an integrative medicine protocol on female breast cancer patients: A prospective quasi experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep M K Nair 
Designation  Chief Medical Officer 
Affiliation  Mirakle Integrated Health Centre 
Address  Room No: 1, Department of Integrative Oncology, NPT-MCET Campus, Udumalai road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone  8667483682  
Fax    
Email  cmo@mirakleihc.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep M K Nair 
Designation  Chief Medical Officer 
Affiliation  Mirakle Integrated Health Centre 
Address  Room No: 1, Department of Integrative Oncology, NPT-MCET Campus, Udumalai road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone  8667483682  
Fax    
Email  cmo@mirakleihc.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep M K Nair 
Designation  Chief Medical Officer 
Affiliation  Mirakle Integrated Health Centre 
Address  Room No: 1, Department of Integrative Oncology, NPT-MCET Campus, Udumalai road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone  8667483682  
Fax    
Email  cmo@mirakleihc.com  
 
Source of Monetary or Material Support  
Mirakle Integrated Health Centre, NPT-MCET Campus, Udumalai Road, Pollachi, Tamil Nadu, India. Pincode - 642003 
 
Primary Sponsor  
Name  Mirakle Integrated Health Centre  
Address  NPT-MCET campus, Udumalai road, Pollachi, Tamil Nadu, India. Pincode - 642003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudarshan S   Mirakle Integrated Health Centre  Address: NPT-MCET campu, Udumalai road, Pollachi Department - Integrative Oncology department Division - Inpatient & Outpatient Room - Research department
Coimbatore
TAMIL NADU 		 8667483682

dr.sudarshanbnys@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mirakle Integrated Health Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mirakle Integrative Medicine protocol  The following intervention are included in the Integrative Medicine protocol: Chemotherapy (Low dose) Oncothermia High dose vitamin C therapy Ozone therapy Diet CoQ 10 enzyme Liposomal curcumin Vitamin D supplementation Artesunate injection Far infra red & Near infra red Coffee enema Probiotic supplementation and other oral nutritional supplementation Colour therapy Magnetic therapy (PEMF & IMRS) Mud therapy Acupuncture Yoga The above mentioned protocol is given for 24 +/- 3 days and then it may be continued based on their disease prognosis study at follow up at 3, 6 and 12 months imaging reports and blood tests. 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Female patients aged 18 years and above with a biopsy proven diagnosis of breast cancer of any stage. Also includes newly diagnosed cases as well as patients who have already undergone conventional, alternative or surgery (mastectomy / lumpectomy) 
 
ExclusionCriteria 
Details  Patients who have psychological or cognitive illness that prevent them from given consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the metabolic response of tumor as per PET Response Criteria in Solid Tumors (PERCIST 1.0)
Changes in tumor biomarkers like CA 15.3, CEA & LDH 		 3 months, 6 months and 12 months follow up  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life using Edmonton Symptom Assessment Scale (ESAS), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30 and CPS
Survival rate  		 After intervention and follow up at 3, 6 & 12 months  
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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 2 
Date of First Enrollment (India)   30/09/2025 
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)  Open to Recruitment 
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   Breast cancer has become a major health crisis in India and globally. Despite the current available standard care the mortality and morbidity rate are raising. To address the metabolic aspect of the tumor a more holistic approach on overall health is required along with the standard care to reduce the cancer burden. Hence, a pragmatic Integrative protocol as been designed by group of doctors from different fields and intervened on patients to study its effectiveness on the metabolic response of the tumor. The study also aims to observe the survival rate and the quality of life with follow up of 1 year. 
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