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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).
Ethanol-induced symptoms questionnaire will be administered three times during the baseline visit (Visit 1) - before, during, and within 30 minutes after treatment with docetaxel - and then during the follow-up visit (or phone call) at 24 hours after the treatment. There will be no restrictions as to what concomitant medications can be used before and after treatment with ethanol-containing docetaxel, and investigators will determine the manufacturer, preparation method, and dosage regimen of docetaxel as per routine care at their study site.
The following data will be collected:
Demographics (gender, age, drinking history)
Height, body weight and body mass index (BMI)
Cancer-related data (diagnosis, date of diagnosis)
ECOG PS
Underlying diseases
Prior and concomitant medications
Data on docetaxel therapy (timing of initiation of the chemotherapy, monotherapy/combination therapy, intervals between chemotherapy treatments, product name, dose (mg), administered ethanol dose (g), blood alcohol content (BAC*), type and volume of intravenous (IV) fluid administered before and after treatment and fluid mixed with docetaxel, duration of injection)
* Blood alcohol content (BAC): Widmark formula = administered ethanol dose (g) / body weight (kg) × gender constant (0.68 for males and 0.55 for females)
Ethanol-induced symptoms questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients receiving chemotherapy with ethanol-containing docetaxel |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ethanol-induced symptoms as a whole | An increase from baseline in the number of ethanol-induced symptoms during or after treatment | Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of each ethanol-induced symptom | Any increase from baseline in the number of each ethanol-induced symptom during or after treatment | Baseline visit - before, during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment |
| Incidence of ethanol-induced symptoms as a whole during and at each time point after treatment |
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Inclusion Criteria:
Exclusion Criteria:
History of psychiatric disorder, seizure, or central nervous system disorder
Metastasis to the central nervous system (although patients without neurological symptoms are eligible)
Active hepatitis
Individuals who meet any of the following:
Combination chemotherapy with ethanol-containing anticancer drugs other than docetaxel
Alcohol, hypnotic or tranquilizer intake within 24 hours before treatment with docetaxel
Pregnant or nursing women or women of childbearing potential
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.
Patients who are otherwise considered by the investigator to be ineligible for this study
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Patients receiving chemotherapy with ethanol-containing docetaxel
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| Name | Affiliation | Role |
|---|---|---|
| Myung Sook Hong | Boryung Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Guri Hospital | Guri-si | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The incidence of ethanol-induced symptoms as a whole will be calculated at each post-dose time point (during, within 30 minutes after treatment, and 24 hours after treatment) compared with baseline values |
| Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment |
| Incidence of each ethanol-induced symptom during and at each time point after treatment | The incidence of ethanol-induced symptoms as each will be calculated at each post-dose time point (during, within 30 minutes after treatment, and 24 hours after treatment) compared with baseline values | Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004935 | Esophageal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |