Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06888505
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed breast cancer (or other cancers as relevant to the study).
* Age 18-70 years.
* Planned treatment with anthracycline-based chemotherapy
* Normal kidney function, defined as serum creatinine 0.6-1.2 mg/dL.
* Normal liver function, defined as ALT and AST 10-40 U/L.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Willingness to participate and provide written informed consent.
Exclusion Criteria:
* History of symptomatic heart failure (NYHA class III-IV) or prior anthracycline-related cardiac dysfunction.
* Previous use of Dapagliflozin.
* Pregnancy or breastfeeding.
* Severe renal impairment (eGFR \< 30 mL/min/1.73m²).
* Uncontrolled diabetes mellitus (HbA1c \> 9%).
* Active or recurrent urinary tract infections (UTIs) within the last 6 months.
* Known hypersensitivity to Dapagliflozin or related compounds.
* Concurrent participation in another clinical trial investigating cardioprotective agents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06888505
Study Brief:
Protocol Section:
NCT06888505