Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 562
Summary
- Conditions
- Breast Cancer
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Cancer
- NSCLC
- Ovarian Cancer
- Prostate Cancer
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
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 t...
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
Tracking Information
- NCT #
- NCT04545632
- Collaborators
- Not Provided
- Investigators
- Study Director: Myung Sook Hong Boryung Pharmaceutical Co., Ltd