| CTRI Number |
CTRI/2025/09/094572 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate Metformins impact on blood, liver and kidney profiles in patients with breast cancer and diabetes |
|
Scientific Title of Study
|
Impact of Metformin on Hematologic and Metabolic Profiles in Patients with Breast Cancer and Type 2 Diabetes Mellitus: Real-World Evidence from a Retrospective Matched Cohort 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 |
Vaishnavi Yanamandra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9705611181 |
| Fax |
|
| Email |
vaishnavi.yanamandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. JEFFREY PRADEEP RAJ |
| Designation |
Associate Professor (Clinical Pharmacology) |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Division of clinical pharmacology, Department of Pharmacology Kasturba
Medical College Manipal University Madhav Nagar Manipal, Udupi, 576104
KARNATAKA
576104
India |
| Phone |
7904286I89 |
| Fax |
|
| Email |
jeffrey.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Yanamandra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
KARNATAKA
576104
India |
| Phone |
9705611181 |
| Fax |
|
| Email |
vaishnavi.yanamandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College Madhavnagar Manipal Karnataka, India 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Vaishnavi Yanamandra |
Kasturba Medical College |
Kasturba Medical College Manipal Karnataka India 576104
Udupi
KARNATAKA |
9705611181
vaishnavi.yanamandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged above 18 years
Histologically confirmed diagnosis of Breast Cancer
Diagnosed with T2DM and receiving anti-diabetic medication
Patient received chemotherapy between 01 Jan 2022 and 31 Dec 2024 |
|
| ExclusionCriteria |
| Details |
Patients with any other concurrent or prior invasive malignancy.
Patients in whom metformin was stopped (for any reason) and shifted to other
antidiabetic agents within 1 month prior to chemotherapy initiation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Hemoglobin |
Baseline and 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Other Hematologic Outcomes
Mean change in RBC counts WBC counts Platelet counts MCV MCH MCHC at
3 and 6 months
b. Proportion of patients with Hb less 11 g per dL at 3 and 6 months
Proportion of patients requiring blood transfusion or erythropoiesis stimulating
agents
Time to occurrence of anemia, defined as Hb less than 11 g per dL |
0 3 6 months |
Renal Outcome
a. Mean change in serum creatinine and creatinine clearance at three and six months
b. Incidence of clinically significant worsening of renal parameters any time during adjuvant or neoadjuvant chemotherapy. Clinically significant worsening of renal parameters during chemotherapy will be defined as either:
An increase in serum creatinine to one and a half times the baseline value or meeting Common Terminology Criteria for Adverse Events version five grade two or higher nephrotoxicity criteria
An acute kidney injury event as per Kidney Disease Improving Global Outcomes guidelines, defined as an increase in serum creatinine of at least zero point three milligrams per decilitre within forty-eight hours or an increase to one and a half times the baseline value within seven days |
0 3 6 months |
Hepatic Outcome
a. Mean change in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total proteins, albumins, globulin and serum bilirubin levels at three and six months
b. Incidence of clinically significant worsening of liver enzyme parameters any time during adjuvant or neoadjuvant chemotherapy. Clinically significant worsening of liver enzyme parameters will be defined as:
An increase in alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal
An increase in total bilirubin greater than one and a half times the upper limit of normal
An increase in alkaline phosphatase greater than two and a half times the upper limit of normal at any time during the adjuvant or neoadjuvant chemotherapy phase |
0 3 6 months |
Exploratory Outcome Measures
a. Hospitalizations related to metabolic or hematologic complications any time during adjuvant or neoadjuvant chemotherapy
b. Delay or dose reduction in chemotherapy due to hematologic toxicity any time during adjuvant or neoadjuvant chemotherapy |
0 3 6 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/10/2025 |
| 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="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
|
The study is a Retrospective Cohort Study based on real world evidence which assesses the impact of Metformin on Hematologic and Metabolic Profiles in Patients with Breast Cancer and Type 2 Diabetes Mellitus which assess the possible hemoprotective, hepatoprotective and renoprotective effects of metformin in patients who are on chemotherapy and antidiabetic medication which involves a broader area of polypharmacy |