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:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT04545632
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who provide written informed consent to collect and use personal information after an explanation of the objectives and methods of the study
2. Adult males and females aged 19 years and older
3. Chemotherapy with ethanol-containing docetaxel (≥50 mg/m2) alone or in combination for a pathologically confirmed cancer
4. ECOG Performance Status (ECOG PS) scores ≤2
5. Patients who are capable of understanding the questionnaire items and directly answering questions
Exclusion Criteria:
1. History of psychiatric disorder, seizure, or central nervous system disorder
2. Metastasis to the central nervous system (although patients without neurological symptoms are eligible)
3. Active hepatitis
4. Individuals who meet any of the following:
* AST/ALT ≥2 X upper limit of normal (ULN)
* Total bilirubin ≥2 X ULN
* Hemoglobin \<9.0 g/dL
5. Combination chemotherapy with ethanol-containing anticancer drugs other than docetaxel
6. Alcohol, hypnotic or tranquilizer intake within 24 hours before treatment with docetaxel
7. Pregnant or nursing women or women of childbearing potential
8. Subjects who are currently participating in another clinical trial (of drugs or medical devices) or plan to do so during the study. However, subjects are allowed to participate in another non-interventional observational study or registry study.
9. Patients who are otherwise considered by the investigator to be ineligible for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04545632
Study Brief:
Protocol Section:
NCT04545632