Preventing heart damage from chemotherapy in breast cancer patients
Evaluation of the Impact of Alpha Lipoic Acid Administration on the Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
This study is testing if a supplement called Alpha lipoic acid can help protect the hearts of Egyptian women from damage while they are receiving chemotherapy for breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | British University In Egypt Academic / other |
| Drugs / interventions | Trastuzumab, chemotherapy, doxorubicin |
| Locations | 1 site (Cairo, El-Sherouk City) |
| Trial ID | NCT06703593 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Alpha lipoic acid (ALA) in preventing cardiotoxicity caused by doxorubicin in Egyptian women undergoing chemotherapy for breast cancer. The trial will monitor changes in echocardiographic findings, serum levels of cardiac biomarkers, and the severity of cardiotoxicity using established criteria. Additionally, the safety of ALA will be assessed through patient interviews and follow-ups regarding potential side effects. The goal is to determine if ALA can mitigate the heart-related side effects of chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old diagnosed with breast cancer who are starting their first cycle of chemotherapy containing anthracyclines.
Not a fit: Patients with a history of heart failure or significant renal or hepatic insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart damage in breast cancer patients receiving doxorubicin.
How similar studies have performed: While some studies have explored cardioprotective strategies during chemotherapy, the specific use of ALA for this purpose in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged more than 18 years 2. Breast cancer diagnosis 3. Entering first cycle of chemotherapy containing ATC 4. Subject must be willing and able to sign an informed consent Exclusion Criteria: 1. History of renal (serum creatinine greater than 2.0 mg/ml) or hepatic insufficiency (bilirubin\> 3.0 mg/dl or serum albumin \< 3.5 g/dl or prothrombin time \< 60% in the absence of orally administered anticoagulant therapy or ultrasound signs of chronic liver damage 2. History of heart failure 3. Baseline LVEF \< 50% determined by transthoracic echocardiogram 4. Current participation in any other clinical investigation 5. History of severe adverse reaction to Alpha lipoic acid 6. Concomitant use of Trastuzumab (HER2 positive patients) 7. Previous intake of alpha lipoic acid in the previous 3 months 8. Women with prior exposure to anthracyclines and neurotoxic agents (Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, isonicotinic acid hydrazide "INH,", etc.) in the last 6 months. 9. Presence of clinical evidence for severe cardiac illness (i.e., angina pectoris and arrhythmias) 10. Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation)
Where this trial is running
Cairo, El-Sherouk City
- The British University in Egypt — Cairo, El-Sherouk City, Egypt (Recruiting)
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.