Clinical trial · Observational
Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor
A Multi-center, Prospective, Observational Study to Evaluate Ethanol-induced Symptoms in Patients With Chemotherapy of Docetaxel
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the incidence and risk factors of ethanol-induced symptoms, this multicenter, prospective, observational study is designed to include patients in Korea who are receiving chemotherapy with ethanol-containing docetaxel alone or in combination. Subjects who voluntarily provide written informed consent to provide information for this study and meet the inclusion/exclusion criteria will be given an enrollment number and will be followed during the observation period to collect study-related data in the Case Report Forms (CRFs) as predefined in the study protocol. Patients' decision to participate (or not) in this study will not affect their treatment (physician's prescriptions or diagnostic/therapeutic decisions).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients receiving chemotherapy with ethanol-containing docetaxel
Primary outcomes (1)
- measure
- Incidence of ethanol-induced symptoms as a whole
- timeFrame
- Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment)
- description
- An increase from baseline in the number of ethanol-induced symptoms during or after treatment
Secondary outcomes (3)
- measure
- Incidence of each ethanol-induced symptom
- timeFrame
- Baseline visit - before, during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
- description
- Any increase from baseline in the number of each ethanol-induced symptom during or after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available