FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081016 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Radiation doses to Cardiac substructures to Identify Cardiotoxicity in left-sided breast cancer patients. 
Scientific Title of Study   Radiation doses to cardiac substructures as a surrogate marker of cardio-toxicity in left breast cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akanksha Solanki 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science,Jodhpur 
Address  Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  09950199906  
Fax    
Email  solankia@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Akanksha Solanki 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science,Jodhpur 
Address  Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  09950199906  
Fax    
Email  solankia@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Akanksha Solanki 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Science,Jodhpur 
Address  Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Room 4, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  09950199906  
Fax    
Email  solankia@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan 342005, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 
Type of Sponsor  Government medical college 
 
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 Akanksha Solanki  All India Institute of Medical Sciences,Jodhpur  Room 5, Department of Radiation Oncology, AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 
9950199906

solankia@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  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  Nil  N/A 
Comparator Agent  Nil  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Biopsy proven patients of left breast cancer, planned for post-operative adjuvant radiation
2. Age 18-65 years
3. ECOG 0-2
4. Absence of pre-existing cardiac condition.
 
 
ExclusionCriteria 
Details  1. Patients treated with palliative intent.
2. Patient of right breast cancer
3. Patients not giving consent for participation.
4. Patient who received prior radiation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
- Correlation of Doses to heart and cardiac substructures with biochemical, radiological and other markers of cardiac injury
- Correlation of Doses to Left anterior descending artery, Left coronary artery and Left ventricle with Mean heart dose.
 
3 and 6 months post radiation 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate various clinicopathological predictors which correlate with presence of cardiac events.  3 and 6 months post radiation 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   03/03/2025 
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 Yet Recruiting 
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  

The most prevalent cancer diagnosed worldwide and among Indian women is now female breast cancer, surpassing lung cancer in prevalence. As per a meta-analysis by EBCTCG, radiotherapy showed an absolute reduction of 15.7% in the 10-year risk of any (ie, locoregional or distant) first recurrence with a modest benefit in overall survival as well. Large cohorts of cancer survivors who underwent RT, either alone or in conjunction with other modalities, are susceptible to late treatment-related complications. Delayed effects on the heart may partially counterbalance the therapeutic benefits of RT, negating those advantages. Virtually any component of the heart can be harmed by exposing a sizable portion of it to radiation at a high enough dose. The main pathophysiology behind this is shown to entail blood vessel injury. Reactive oxygen species are hypothesised to be responsible for this damage by disrupting DNA strands. Fibrosis follows secondary inflammatory alterations. This then leads to a vicious cascade of events such as intimal fibrosis, atherosclerosis, decreased coronary perfusion and other ischemic or conduction abnormalities. Although vessel injury is postulated to be a major player in the cardiac events associated with breast cancer radiation, Mean heart dose rather than doses to various cardiac substructures still remain the standard of care at most centres while prescribing dose constraints during Breast radiotherapy in the absence of strong conclusive data. Thus, the objective of this study is to assess the correlation between Mean cardiac dose, doses to cardiac substructures and their contribution to cardiac events.

 
Close