| CTRI Number |
CTRI/2020/10/028628 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
The effect of cancer treatment and anaesthesia on your heart. |
|
Scientific Title of Study
|
The Cardio-toxicity of Cancer Chemotherapy And Anaesthesia - A Prospective Observational Study |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajani Thabah |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Department of Anaesthesia
OPD first floor
Room no 105
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Department of Anaesthesia
OPD first floor
Room no 105
East Khasi Hills
MEGHALAYA
7930018
India |
| Phone |
9485098914 |
| Fax |
- |
| Email |
rajanithabah@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Thabah |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Anaesthesia Department
OPD first floor
Room no 105
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Anaesthesia Department
OPD first floor
Room no 105
East Khasi Hills
MEGHALAYA
7930018
India |
| Phone |
9485098914 |
| Fax |
- |
| Email |
rajanithabah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Thabah |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Anaesthesia Department
First floor OPD
Room no 105
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences.
Anaesthesia Department
First floor OPD
Room no 105
East Khasi Hills
MEGHALAYA
7930018
India |
| Phone |
9485098914 |
| Fax |
- |
| Email |
rajanithabah@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Intramural Grant from North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
Mawdiangdiang
Shillong 793018
Meghalaya
India |
|
|
Primary Sponsor
|
| Name |
Intramural Grant |
| Address |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
Mawdiangdiang
Shillong 7930018
East Khasi Hills
Meghalaya, India |
| Type of Sponsor |
Research institution and 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 Rajani Thabah room no OPD |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
Mawdiangdiang
Shillong 793018
Meghalaya
India
East Khasi Hills
MEGHALAYA |
9485098914
-
rajanithabah@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe, NEIGRIHMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who have received cardiotoxic cancer chemotherapy
- Patients more than 18 years
- Patients of either sex
- ASA physical status I and II
- Patients posted for elective surgery
|
|
| ExclusionCriteria |
| Details |
- Patients with post radiotherapy
- Patients who have received non cardiotoxic cancer chemotherapy
- ASA physical status III and IV
- Patients with pre-existing cardiac diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Preoperative MET level
- Preoperative chest x-ray findings
- Preoperative ECG findings
- Preoperative echogardiography findings |
Preoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Postoperative MET level
- Postoperative chest x-ray findings
- Postoperative ECG finding
- Postoperative echocardiology findings |
Postoperative |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/10/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Plan to publish after the trial is over |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients who have received cancer chemotherapy also experience the toxic effects of the therapy. Many studies have shown that chemotherapy induced cardiac dysfuntion is a major contributor in morbidity and mortality rate. The myocardial depressant effect of anaesthesia can exacerbate the cardoitoxic side effect of cancer chemotherapy. Various other factors like surgical pathology, extend of surgery and age related physiology are directly related to mortality. Thus, we expect that there will be an increase or development of new cardiovascular complications postoperatively
|