Alpha-Lipoic Acid in Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2019-10-01
• Target enrollment: 50
• Participant gender: Female

Summary

• Investigate the ability of alpha lipoic acid to counter act anthracycline associated cardiotoxicity and cumulative taxens-related PN in patients with breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Thioctic Acid

Criteria

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