| CTRI Number |
CTRI/2024/10/076039 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of changes in heart function of carcinoma esophagus patients receiving radiotherapy |
|
Scientific Title of Study
|
Evaluation of changes in early indicators of cardiac dysfunction in esophageal cancer patients receiving radiotherapy-A Prospective Observational 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 |
Pooja Doley |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Radiation Oncology
AIIMS Rishikesh
Pin 249203
Pashulok
AIIMS Rishikesh,District: Dehradun,Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
08255066502 |
| Fax |
|
| Email |
doleypooja25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Joseph |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Radiation Oncology
AIIMS Rishikesh
Pin 249203
Pashulok
AIIMS Rishikesh
Department of Radiation Oncology
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8978386509 |
| Fax |
|
| Email |
drdeepajoseph@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Joseph |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Radiation Oncology
AIIMS Rishikesh
Pin 249203
Pashulok
Department of Radiation Oncology , AIIMS Rishikesh,District: Dehradun,Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8978386509 |
| Fax |
|
| Email |
drdeepajoseph@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh,Virbhadra Road,Rishikesh,Uttarakhand,India, Pin: 249203 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
N/A |
| Type of Sponsor |
Other [Study will be carried out in patients receiving treatment in the hospital.] |
|
|
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 Pooja Doley |
AIIMS Rishikesh |
Department of Radiation Oncology
AIIMS Rishikesh
Pin 249203
Pashulok
Hostel 86,Room no 317, AIIMS Rishikesh,District: Dehradun,Uttarakhand
Dehradun
UTTARANCHAL |
08255066502
doleypooja25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1.Age above 18 years
2.Histologically proven cases of carcinoma esophagus
3.Patients receiving radiotherapy as a part of curative treatment. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1.Previous history of radiotherapy to thorax
2.Recurrent disease
3.Metastatic disease
4.Tracheoesophageal fistula
5.Cervical esophageal cancer
6.Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any changes in coronary calcium scoring post radiotherapy in CT scan. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/11/2024 |
| 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="0"
Months="8"
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
|
Esophageal cancer is one of the most common malignancies of the gastrointestinal tract. As per GLOBOCAN 2020, it is the 9th most common cancer in the world. Radiotherapy is one of the most effective treatments for both resect able and unresectable esophageal cancer. Radiotherapy can improve outcomes in esophageal cancer, however when irradiation field includes the heart, late cardiac effects can develop. Radiotherapy has been proven to raise overall survival rates in esophageal cancer patients. Due to improvements in outcomes, cancer survival has increased and there is growing focus on long -term treatment related toxicity. Cardiovascular diseases associated with chest irradiation are pericarditis, coronary artery disease, valvular heart disease, conduction abnormalities and restrictive cardiomyopathy. These changes ultimately lead to cardiac wall abnormalities and heart failure. This study is being carried out to observe changes in early indicators of cardiac dysfunction post radiotherapy in carcinoma esophagus patients. It will be done in 20 patients. Studies will include detailed history and physical examination, complete hemogram, upper GI endoscopy with biopsy, CECT Whole abdomen + Thorax or PET CT for staging and metastatic work-up. Baseline cardiac evaluation with 12 lead ECG,2D ECHO and Cardiac MRI. Coronary calcium scoring will be recorded with Weston scoring technique in radiotherapy planning CT scan. Coronary calcium scoring,2D ECHO, ECG and Cardiac MRI will be done post treatment to see any changes from baseline. |