Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06703593
Eligibility 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT06703593
Study Brief:
Protocol Section:
NCT06703593