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CTRI Number  CTRI/2025/07/091899 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Why Some Breast Cancer Patients Get Anemia During Chemotherapy By Using Past Medical Records 
Scientific Title of Study   Factors Associated With Anemia In Breast Cancer Patients Undergoing Chemotherapy: A Retrospective 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  Sakshi G 
Designation  PG student 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7996899120  
Fax    
Email  sakshianchan33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandakumar UP 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9633023062  
Fax    
Email  nandakumar@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Nandakumar UP 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer, Deralakatte, Mangaluru


KARNATAKA
575018
India 
Phone  9633023062  
Fax    
Email  nandakumar@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University) Paneer, Deralakatte, Mangaluru, Karnataka 575018 
Justice KS Hegde Charitable Hospital, Deralakatte, Manglauru, Karnataka 575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University) Paneer, Deralakatte, Mangaluru, Karnataka 575018 
Type of Sponsor  Other [Academic Institute] 
 
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 T Krishna Sharan  Justice KS Hegde Charitable Hospital  Room No: 76, lower ground floor, Department of Radiology and Oncology, Justice KS Hegde Charitable Hospital
Dakshina Kannada
KARNATAKA 
9448625116

drkrishna.sharan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS- IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Female breast cancer patients, aged above 18 years, who had undergone adjuvant chemotherapy.
2. Patients with normal haemoglobin count (Greater than or equal to 12 g/dl) before initiation of first cycle of adjuvant chemotherapy  
 
ExclusionCriteria 
Details  1. Patients who received blood transfusion within two weeks before chemotherapy
2. Patients with metastatic breast cancer
3. Patients who had underwent experimental trial of chemotherapy
4. Patients with incomplete medical records
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
By identifying the factors associated with anemia among breast cancer patients undergoing chemotherapy, this study is expected to offer valuable insights for refining supportive care strategies  8 months  
 
Secondary Outcome  
Outcome  TimePoints 
To help clinicians in early risk assessment and to plan interventions to improve patient outcomes.  8 months 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
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)   25/08/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
 INTRODUCTION
 Breast cancer remains one of the most prevalent malignancies worldwide, posing a significant health burden. Following the diagnosis of breast cancer, a patient has to undergo various therapies including chemotherapy. However, this treatment is associated with several adverse effects, with anemia being a particularly concerning complication. 
 OBJECTIVES OF THE STUDY
 To determine the proportion of anemia among breast cancer patients undergoing adjuvant chemotherapy and to identify the factors associated with anemia in these patients.
 METHODOLOGY
 This retrospective study will be conducted among female breast cancer patients aged above 18 years with normal hemoglobin levels before starting adjuvant chemotherapy. Details pertaing to the socio-demographic and clinical parameters of the subjects presented between January 2015 and December 2024 will be collected from their medical records. Hemoglobin values recorded at the beginning of each chemotherapy cycle will be extracted from medical records for up to a maximum of eight cycles. The lowest hemoglobin value documented during the first eight cycles of adjuvant chemotherapy will be used to determine the severity of anemia in participants. 
 STATISTICAL ANALYSIS 
 Statistical aalysis will be done using SPSS version 29.0 with a 95% confidence interval. Qualitative data will be shown as frequency and percentage, while quantitative data will be presented as mean and standard deviation. The proportion of anemia will be expressed as frequency and percentage, and factors associated with anemia will be analyzed using the chi square test. A p-value of less than 0.05 will be considered statistically significant. 
 OUTCOME MEASURES
 By identifying the factors associated with anemia among breast cancer patients undergoing chemotherapy, this study is expected to offer valuable insights for refining supportive care strategies. The findings can help clinicians in early risk assessment and to plan interventions to improve patient outcomes.     
 
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