| 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
|
|
|
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
|
|
|
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. |