CTRI Number |
CTRI/2023/11/059490 [Registered on: 03/11/2023] Trial Registered Prospectively |
Last Modified On: |
02/11/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
A study to evaluate the efficacy & safety of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia |
Scientific Title of Study
|
A prospective efficacy & safety study of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia |
Trial Acronym |
FCM study |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr K Manjunath Nookala |
Designation |
Associate Professor, Dept. of Clinical Pharmacology |
Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Address |
Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
Phone |
919920703438 |
Fax |
|
Email |
nk.manjunath@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr K Manjunath Nookala |
Designation |
Associate Professor, Dept. of Clinical Pharmacology |
Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Address |
Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai
MAHARASHTRA 410210 India |
Phone |
919920703438 |
Fax |
|
Email |
nk.manjunath@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr K Manjunath Nookala |
Designation |
Associate Professor, Dept. of Clinical Pharmacology |
Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Address |
Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai
MAHARASHTRA 410210 India |
Phone |
919920703438 |
Fax |
|
Email |
nk.manjunath@gmail.com |
|
Source of Monetary or Material Support
|
Emcure pharmaceuticals Ltd |
|
Primary Sponsor
|
Name |
Emcure Pharmaceuticals Ltd |
Address |
Plot P-II, IT-BT Park, M.I.D.C., Hinjawadi, Pune- 411 057 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
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 Manjunath Nookala Krishnamurthy |
Tata Memorial Centre (TMH and ACTREC) |
Department of Clinical Pharmacology, Room No. KS 102, Khanolkar Shodhika, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre,
Kharghar
Navi Mumbai Raigarh MAHARASHTRA |
9920703438
nk.manjunath@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee III |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (8) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (9) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Inj.Ferric Carboxy Maltose |
Inj. Ferric Carboxy Maltose is given as 1 gram injection over a period of 10-15 infusion |
Comparator Agent |
This is a single arm trial |
There is no comparator in this study |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
1. Females 18 yrs or older
2. Histologically proven diagnosis of breast cancer patients on follow-up, rather than on ongoing chemotherapy.
3. Haemoglobin 8-10g/dl or transferrin saturation ≤20% regardless of the haemoglobin level. |
|
ExclusionCriteria |
Details |
1. Patients with other obvious known causes of anaemia like blood loss,
Megaloblastic anaemia, Pernicious anaemia, and Haemolytic anaemia
2. Patients who are a known case of uncontrolled hypertension, recent acute
illness, hematologic disorders, or those receiving any other experimental drug
3. Patients with a known significant dysfunction of pulmonary, cardiovascular,
endocrine, neurological, gastrointestinal, or genito-urinary systems not
attributable to underlying malignancy
4. Patients who are receiving Iron supplements in oral or parenteral forms
5. Patients who are on erythropoietin stimulating agents
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine the efficacy of IV Ferric CarboxyMaltose in breast cancer patients with iron deficiency anaemia |
Change in the Haemoglobin level at 30±7 days from immediate preFCM Haemoglobin leve |
|
Secondary Outcome
|
Outcome |
TimePoints |
To determine the safety of IV Ferric CarboxyMaltose in breast cancer
patients with iron deficiency anaemia
|
-Incidence of all grade adverse events
-Incidence of Grade 3/4 adverse events |
To study the impact of IV Ferric Carboxy Maltose on the quality of life of
metastatic breast cancer patients with iron deficiency anaemia |
Change in the patient’s quality of life at 30±7 days after the administration of IV FCM from immediate pre-FCM Haemoglobin level |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
10/11/2023 |
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 Applicable |
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
|
Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide with 2.26 million [95% UI, 2.24–2.79 million] new cases in 2020. Anaemia in cancer patients is still a relevant problem and is the most common complication in them. Anaemia affects both general health and quality of life. It has an incidence rate ranging from 22.7% to 63% and increasing to 89% following chemotherapy. It can be classified into two important forms: (1) anaemia occurring as an adverse event consequent to the toxic effect of anticancer treatment (chemotherapy-induced anaemiaâ€) and (2) anaemia occurring as a manifestation of the disease itself, more aptly called “cancer related anaemia,†resulting from systemic processes and immune system activation in cancer. Anaemia may be induced by the direct myelotoxic effect of the chemotherapeutic agents or indirectly by drug-induced renal damage resulting in low levels of erythropoietin (EPO). FCM is reported to be safe and effective in providing a rapid correction of serum ferritin levels and Hb in IDA patients. Despite the availability of several other iron formulations like LMW Iron dextran, Ferric gluconate, and Ferumoxytol, the use of FCM has improved the physical performance and quality of life in iron-deficient patients compared to other iron formulations FCM is reported to be with occurrence of less adverse events compared to other formulations. This study attempts to assess the safety and efficacy of IV FCM in increasing the Hb in IDA in Breast Cancer patients who are on follow-up and thereby decreasing eventual and inevitable blood transfusions. It will be a prospective, non-randomized, single-arm study in breast cancer patients with iron deficiency anaemia (IDA) who have completed chemotherapy and are in follow-up stage. |