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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT06406127
Eligibility Criteria:
Inclusion Criteria:
* Female breast cancer patients aged 18 to 75 years old.
* Patients with a first diagnosis of cancer and indication for first-line therapy with Paclitaxel-based chemotherapy.
* Patients are those who are diagnosed with Stage 1 to 3 non-metastatic breast cancer.
* Patients are intended to receive 12 weeks of paclitaxel (75 - 80 mg/m2) according to the TC protocol.
* No previous neurological conditions (including dementia, Alzheimer's disease, Parkinson's disease) and taking no neurological-related drugs.
* Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).
* Eastern Cooperative Oncology Group (ECOG) performance status from 0 - 2.
* Patient Health Questionnaire (PHQ) score from 0 - 9.
Exclusion Criteria:
* Hypersensitivity / Allergy to Alpha Lipoic Acid.
* Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
* New-onset neurological symptoms or presence of any neurological disorder.
* Patients with known history or current treatment with neurological agents.
* Alcohol abuse.
* Current participation in any other clinical investigation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06406127
Study Brief:
Protocol Section:
NCT06406127