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:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT03908528
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03908528
Study Brief:
Protocol Section:
NCT03908528