| 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
|
|
|
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
|
|
|
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. |