Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Kasturba Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HemoglobinTimepoint: Baseline and 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 dLTimepoint: 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 daysTimepoint: 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 phaseTimepoint: 0 3 6 month | — |
Countries
India
Contacts
Public ContactVaishnavi Yanamandra
Kasturba Medical College, Manipal
Outcome results
None listed