Clinical trial · Interventional
Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
Evaluation of the Impact of Alpha Lipoic Acid Administration on the Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
According to the European Society of Cardiology 2022, the primary prevention of cancer therapyrelated cardiovascular toxicity during anthracycline chemotherapy include renin-angiotensin- aldosterone system blockers, beta-blockers, and mineralocorticoid receptor antagonists that have shown a significant benefit in preventing left ventricular ejection fraction (LVEF) reduction, but with no statistical differences in the incidence on the various other clinical outcomes as overt congestive heart failure (CHF). Also, other strategies have been investigated including; adjusting the infusion time and dose intensity of anthracyclines. Dexrazoxane and liposomal anthracyclines are currently approved in patients with high and very high chemotherapy-related cardiovascular disease (CTRCD) risk or who have already received high cumulative anthracyclines doses (Lyon, 2022). The incidence is about 4% when the dose of doxorubicin is 500-550 mg/m2, 18% when the dose is 551-600 mg/m2 and 36% when the dose exceeds 600 mg/m2 (Lefrak, 1973). Alpha-lipoic acid (ALA) was reported to have a cardioprotective role against doxorubicin-induced cardiotoxicity through attenuation of oxidative stress via scavenging reactive oxygen species (ROS), regenerating endogenous antioxidants including glutathione, vitamin E, and C, its metal chelation activity and its ability to repair oxidative damage. (Werida et al, 2022)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha lipoic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Alpha Lipoic acid intervention arm
- description
- Alpha Lipoic acid 1200 mg daily for 6 months
- interventionNames
- Drug: Alpha lipoic acid
- type
- NO_INTERVENTION
- label
- No intervention arm
- description
- not taking Alpha Lipoic acid
Primary outcomes (2)
- measure
- Changes in echocardiographic findings
- timeFrame
- Approximately few days ( less than a week ) before Cycle 1 "baseline" and after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
- description
- Elevation or maintenance of Ejection fraction percentage (EF %)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available