| CTRI Number |
CTRI/2019/05/019378 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Will Intravenous Inron reduce blood transfusion in patients undergoing treatment for ovarian cancer |
|
Scientific Title of Study
|
Clinical experience with intravenous iron in anaemic patient receiving cancer treatment for epithelial ovarian carcinomas |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama R |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Gynecologic Oncology
Amrita Institute of Medical Sciences
Ponekkara
Ernakulam
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamashyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama R |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Gynecologic Oncology
Amrita Institute of Medical Sciences
Ponekkara
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamashyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama R |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Gynecologic Oncology
Amrita Institute of Medical Sciences
Ponekkara
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamashyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences
Amrita University
Ponkkara P O, Kochi, Kerala 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita University |
| Address |
Amrita Vishwavidyapeetham, Coimbatore |
| Type of Sponsor |
Research institution |
|
|
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 |
| Anupama R |
Amrita Institute of Medical Sciences |
Department of Gynecologic Oncology, Tower 3 Ground Floor , Room number 2. Amrita institute of Medical Sciences, Ponekkara
Ernakulam
KERALA |
8891728600
anupamashyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ferric carboxy maltose |
Dose 500 mg
Route Intravenous after after diluting in 500 ml Normal saline
Frequency - Once . At the detection of anaemia |
| Comparator Agent |
Oral Iron |
Dose 100mg
Route oral
Frequency Once a day for 3 months after detection of anaemia
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
age 18–75 years with normal liver and kidney function, no prior radiotherapy
and an Eastern Cooperative Oncology Group (ECOG) performance status
of ≤2
-Patient with epithelial ovarian cancer receiving Neoadjuvant or adjuvant chemotherapy or planned for surgery , having Hemoglobin level ≤10 gm/dL
|
|
| ExclusionCriteria |
| Details |
Erythropoitin Stimulating Agent administration during chemotherapy course
-Allergic reaction to ferric carboxymaltose
- Serum ferritin >800 ng/mL OR serum trasferrin saturation >50%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Blood transfusion
Improvement in haemoglobin |
At three months
Completion of chemotherapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvemnet in Serum ferritin, Serum Iron levels and Total Iron Binding capacity |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "69"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2019 |
| Date of Study Completion (India) |
01/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is planned as a prospective randomised controlled trial to evaluate the efficacy of parenteral iron supplementation using ferric carboy maltose in patients undergoing treatment (chemotherapy/ surgery) for epithelial ovarian cancer. 30 patients each will be included in the interventional and control arm. the intervention group will receive parenteral iron if the haemoglobin is less than 10gm%. The control group will be treated with oral iron. Primary outcomes measured will be improvement in haemoglobin and number of units of blood transfused. |