Using Dapagliflozin to Prevent Heart Damage from Chemotherapy
Mitigating Chemotherapy-Induced Cardiac Toxicity with Dapagliflozin
This study is testing if the drug Dapagliflozin can help protect the hearts of cancer patients getting chemotherapy from damage caused by their treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hawler Medical University Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, doxorubicin |
| Locations | 1 site (Duhok) |
| Trial ID | NCT06888505 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Dapagliflozin, an SGLT2 inhibitor, in preventing chemotherapy-induced cardiotoxicity in patients undergoing treatment with anthracyclines and trastuzumab. The study involves a randomized controlled design where participants will receive either Dapagliflozin or a placebo while being monitored for cardiac function. The trial aims to address the significant risk of heart failure and other cardiovascular complications associated with these cancer therapies. By evaluating the cardioprotective properties of Dapagliflozin, the study seeks to improve patient outcomes during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with histologically confirmed breast cancer or other relevant cancers who are scheduled to receive anthracycline-based or trastuzumab-based chemotherapy.
Not a fit: Patients with a history of symptomatic heart failure or prior anthracycline-related cardiac dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart damage in cancer patients receiving chemotherapy.
How similar studies have performed: While the use of SGLT2 inhibitors for cardioprotection is emerging, this specific application in the context of chemotherapy-induced cardiotoxicity is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed breast cancer (or other cancers as relevant to the study). * Age 18-70 years. * Planned treatment with anthracycline-based and/or trastuzumab-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.
Where this trial is running
Duhok
- Azadi Oncology Centre — Duhok, Iraq (Recruiting)
Study contacts
- Principal investigator: Hakar A Saeed, M.Sc — university of zakho
- Study coordinator: Hakar A Saeed, M.Sc.
- Email: hakar.sindy@yahoo.com
- Phone: 009647504711359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.