| CTRI Number |
CTRI/2024/09/073458 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of chemotherapy on coagulation profile in Breast Cancer |
|
Scientific Title of Study
|
Effect of Chemotherapy on Coagulation Profile in cases of Breast Carcinoma |
| 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 Wahida Iyamin Hussain |
| Designation |
Post Graduate Trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Surgery
Silchar Medical College and Hospital
Ghungoor Cachar Assam India
Cachar
ASSAM
788014
India |
| Phone |
8011000705 |
| Fax |
|
| Email |
Wahida.daisy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debabrata Singha |
| Designation |
Professor and Guide |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Surgery
Silchar Medical College and Hospital
Ghungoor Cachar Assam India
Pin 788014
Cachar
ASSAM
788014
India |
| Phone |
9435072017 |
| Fax |
|
| Email |
Debabrata.singha12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debabrata Singha |
| Designation |
Professor and Guide |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of General Surgery
Silchar Medical College and Hospital
Ghungoor Cachar Assam India
PIN 788014
Cachar
ASSAM
788014
India |
| Phone |
9435072017 |
| Fax |
|
| Email |
Debabrata.singha12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital
Ghungoor Cachar Assam India
Pin 788014 |
|
|
Primary Sponsor
|
| Name |
DR WAHIDA IYAMIN HUSSAIN |
| Address |
Department of General Surgery
Silchar Medical College and Hospital
Ghungoor Cachar Assam India
Pin 788014 |
| Type of Sponsor |
Other [SELF ] |
|
|
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 Wahida Iyamin Hussain |
Silchar Medical College and Hospital |
Department of General Surgery
Silchar Medical College and Hospital
Ghungoor Cachar Assam India
Pin 788014
Cachar
ASSAM |
8011000705
Wahida.daisy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SILCHAR MEDICAL COLLEGE AND HOSPITAL |
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 |
Chemotherapy Drugs |
CAF regimen (repeat cycle every 21 days )-
Cyclophosphamide 600 mg/m2 IV on Day 1
Doxorubicin 60mg/m2 IV on Day 1
5-flourouracil 600/m2 IV on Day 1
CMF regimen (repeat cycle every 21 days)
Cyclophosphamide 600 mg/m2 IV on Day 1
Methotexate 40mg/m2 IV on Day 1
5-flourouracil 600/m2 IV on Day 1
ACT regimen (cycle repeated every 21 days)
Doxorubicin 60mg/m2 IV on Day 1
Cyclophosphamide 600 mg/m2 IV on Day 1
Paclitaxel 175/m2 IV on Day 1
Duration of therapy for all 3 regimens:
In case of Neoadjuvant therapy - 3 cycles
In case of adjuvant therapy- 6 cycles
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All cases of breast carcinoma |
|
| ExclusionCriteria |
| Details |
1 patients who are unwilling to participate
2 Patients unwilling to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in values of -
Platelet count
PT INR
APTT
D Dimer
Bleeding Time
Clotting time |
1 Before starting chemotherapy
2 On Day 3 post chemotherapy
3 On day 14 post chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/09/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Cancer is associated with increased risk of thrombosis. Up to 15% of patients with clinically overt cancers present with venous thromboembolism during the course of their disease. breast cancer is the most common site specific cancer in women. an increased incidence in these thromboembolic events have been noted in women receiving chemotherapy. The main mechanisms of thrombus formation associated with chemotherapeutic agents are- 1. the release of procoagulants and cytokines from the tumour cells damaged by the cell targeted treatment 2. a toxic effect towards the vascular endothelium 3. The fall of naturally occurring anticoagulants |