NCT04545632

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 458 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 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

Conditions

• Breast Cancer
• NSCLC
• Prostate Cancer
• Head and Neck Cancer
• Gastric Cancer
• Esophageal Cancer
• Ovarian Cancer

Timeline

• Start date: 2020-06-10
• Primary completion: 2021-02-26
• Completion: 2021-06-24
• First posted: 2020-09-11
• Last updated: 2022-07-27

Locations

1 site across 1 country: South Korea