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CTRI Number  CTRI/2022/06/043104 [Registered on: 08/06/2022] Trial Registered Prospectively
Last Modified On: 06/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To find the number of cancer patients having lower than normal healthy red blood cell due to low iron in body, and how this affects their treatment 
Scientific Title of Study   Prevalence of iron deficiency anemia in cancer patient and therapeutic outcomes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Malini Mohan 
Designation  Registrar 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Medical Oncology, Shirdi Sai baba cancer hospital and research centre, Kasturba Medical college, Manipal, Udupi
Kasturba Medical college, Manipal, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9495991228  
Fax    
Email  dr.malini.mohan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karthik Udupa 
Designation  Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Medical Oncology, Shirdi Sai baba cancer hospital an research centre, Kasturba Medical college, Manipal, Udupi
Kasturba Medical college, Manipal, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9845317153  
Fax    
Email  udupa.k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthik Udupa 
Designation  Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Medical Oncology, Shirdi Sai baba cancer hospital an research centre, Kasturba Medical college, Manipal, Udupi
Kasturba Medical college, Manipal, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9845317153  
Fax    
Email  udupa.k@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical college, Manipal 
 
Primary Sponsor  
Name  Dr Malini Mohan 
Address  Department of Medical Oncology, Shirdi Sai baba cancer hospital and research centre, Kasturba Medical college, Manipal, Udupi 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Malini Mohan  Kasturba Medical College, Manipal, Udupi  Department of Medical Oncology, 1st floor, Shirdi Sai baba cancer hospital and research centre
Udupi
KARNATAKA 		 9495991228

dr.malini.mohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC & KH institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Hemoglobin level less than or equal to 10 g/dL
- Transferrin saturation < 20 %
- Any stage solid malignancies 
 
ExclusionCriteria 
Details  - Age less than 18yrs
- Pregnant women
- any evidence of hemolysis
- Active gastrointestinal bleeding (stool occult blood positive)
- active infection requiring systemic antibiotics
- HIV infection
- active Tuberculosis infection
- liver/ renal dysfunction - Grade 2 or higher based on National Cancer Institute Common Toxicity Criteria: Bilirubin >1.5 times normal, Transaminases >2.5 times normal), renal dysfunction (serum creatinine levels > or equal to 2.0 mg/dL)
- Malignant Bone marrow infiltration
-Received iron supplementation / blood transfusion in the preceding 4 weeks
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Prevalence of patients with absolute and functional iron deficiency anemia
 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
a)Best response to treatment - Response will be defined as proportion of patients achieving an increase in hemoglobin at any time from baseline to end of 12 weeks. Response criteria is defined as follows: -
Complete response : increase in Hemoglobin level 2.0 g/dL above baseline, and/ or transfusion free.
Partial response : increase in Hemoglobin level (1g/dL-2g/dL) above baseline
Minor response : increase in Hemoglobin level ( 0.5 g/dL-1g/dL) above baseline

b)Efficacy assessment with quality of life questionnaire (Functional assessment of cancer therapy- Anemia ( FACT An ))
 		 2 years 
 
Target Sample Size   Total Sample Size="323"
Sample Size from India="323" 
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)   15/06/2022 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective  observational study in which we aim to assess the burden of iron deficiency anemia in cancer patients visiting Kasturba Medical College, Manipal. Those patients detected to have iron deficiency anemia will be given iron supplementation and we will assess the efficacy of the same.Use of intravenous iron for treatment has effectively helped in reducing the need for frequent blood transfusions. It also has better tolerability profile compared to oral iron.  
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