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CTRI Number  CTRI/2024/02/062803 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Anemia in advanced cancer patients 
Scientific Title of Study   Prevalence of anemia and associated factors in patients with advanced cancer receiving palliative care - a cross sectional study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raghu S Thota 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room no. MB-75, Department of Palliative Medicine, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  ragstho24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Raghu S Thota 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room no. MB-75, Department of Palliative Medicine, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  ragstho24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raghu S Thota 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room no. MB-75, Department of Palliative Medicine, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax    
Email  ragstho24@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai, 40012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Parel, Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
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 Ajila A  Tata Memorial Hospital  Room no. MB-75, Department of Palliative Medicine, Tata Memorial Hospital
Mumbai (Suburban)
MAHARASHTRA 		 24177000

ajilaajithkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged more than or equal to 18 years.  
 
ExclusionCriteria 
Details  1) Patients presenting with symptoms requiring emergency medical services
2) Patients suffering from acute psychiatric or neurocognitive disorders
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Prevalence of anaemia in patients with advanced malignancy by using WHO cut offs for hemoglobin values on the day of OPD visit; prevalence will be represented as frequencies and percentage of patients with anemia.  Base line 
 
Secondary Outcome  
Outcome  TimePoints 
1) Frequency & percentage of patients with anaemia according to severity into mild, moderate & severe based on haemoglobin levels.
2) Frequency & percentage of patients anaemia according to WHO morphological classificationinto microcytic, normocytic & macrocytic according to MCV levels.
3) Type & severity of symptoms as mild, moderateand severe on their 1st visit using ESAS r represented as median scores.
4) Demographical& Clinical factors associated with anemia in patients with advanced malignancy.
5) Frequency & percentages of the type of interventions received for anaemia -multivitamins, oral iron therapy,intravenous iron therapy, blood transfusions, erythropoietin received in the last 4 weeks .
 		 Base line 
 
Target Sample Size   Total Sample Size="651"
Sample Size from India="651" 
Final Enrollment numbers achieved (Total)= "651"
Final Enrollment numbers achieved (India)="651" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) 25/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Study Topic: PREVALENCE OF ANEMIA AND ASSOCIATED FACTORS IN PATIENTS WITH ADVANCED CANCER RECEIVING PALLIATIVE CARE- A CROSS-SECTIONAL STUDY

 

 

This study’s main aim is to assess the prevalence of anemia and understand the factors associated with anemia in patients with advanced solid malignancy referred to Palliative Medicine Department.

The purpose is to not only aimed at understanding anaemia prevalence  among palliative cancer patients in Indian population ,but also to understand the symptom burden that is arising because of cancer and cancer treatments; in long-term, the quality of life.

This study also tries to bring light into areas of interventions such as blood transfusions and pharmacological treatments for anaemia in palliative cancer patients which is still unexplored.

Participants will be screened and  those who fulfil criteria will be successfully enrolled in the study. Participants will be open to a medical history and symptom assessment. Data from participants will be analysed to estimate the prevalence of anaemia, symptom profile and associated factors in this population. This study will help us in better patient management and plan appropriate interventions in specialist palliative care setting.

 
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