Clinical trial · Interventional
Alpha-Lipoic Acid in Breast Cancer Patients
Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients
NCT03908528CI-TRIAL-00054371completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
• Investigate the ability of alpha lipoic acid to counter act anthracycline associated cardiotoxicity and cumulative taxens-related PN in patients with breast cancer.
Conditions
Conditions (2)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) | Dietary Supplement | — | UNRESOLVED |
| Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus Placebo for six Months
- description
- • Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus Placebo.
- interventionNames
- Other: Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus alpha lipoic acid for six Months
- description
- • Group two: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks in addition to oral 600 mg alpha lipoic acid (ALA) once daily.
- interventionNames
- Dietary Supplement: Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients age ≥ 18 and \< 70 years old with confirmed stage from stage I to stage III. 2. No evidence of metastases at initial assessment. 3. Patients has to have a good performance status (ECOG 0-2) according to Eastern Cooperative Oncology Group (ECOG) score. 4. Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin level ≥ 10g/dL). 5. Patients with adequate liver function (serum creatinine \< 1.5 mg/dL) and adequate renal function (serum creatinine \< 1.5 mg/dL, creatinine clearance (CrCl) \> 45 ml/min). 6. Either pre operative or post operative chemotherapy are allowed. Exclusion Criteria: 1. Evidence of metastases at initial assessment. 2. Pregnancy or breast-feeding patients. 3. Prior exposure to neurotoxic chemotherapy was not allowed (no carboplatin, vincristine, vinblastine, paclitaxel, or docetaxol ) for 6 months prior study treatment. 4. Clinical evidence of serious cardiac illness (myocardial dysfunctional, angina pectoris requiring anti-angina medication, poorly controlled hypertension, and uncontrolled arrhythmias). 5. Patients with a reduced cardiac output with a left ventricular ejection fraction (LVEF) ejection fraction \< 50%. 6. Patients who had evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes). 7. Patients with a history of allergy to alpha-lipoic acid. 8. Concomitant use of multivitamins (vitamin E), opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication modifying agents (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are not allowed
References
Publications (2)
- BACKGROUNDKapoor S. The Anti-neoplastic Effects of Alpha-Lipoic Acid: Clinical Benefits in System Tumors besides Lung Carcinomas. Korean J Thorac Cardiovasc Surg. 2013 Apr;46(2):162-3. doi: 10.5090/kjtcs.2013.46.2.162. Epub 2013 Apr 9. No abstract available. PMID 23614108
- DERIVEDWerida RH, Elshafiey RA, Ghoneim A, Elzawawy S, Mostafa TM. Role of alpha-lipoic acid in counteracting paclitaxel- and doxorubicin-induced toxicities: a randomized controlled trial in breast cancer patients. Support Care Cancer. 2022 Sep;30(9):7281-7292. doi: 10.1007/s00520-022-07124-0. Epub 2022 May 21. PMID 35596774