Docetaxel Ethanol-induced Symptoms; The Incidence & Risk Forecating Factor

Status Completed

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04545632
Study type	Observational
Source	Boryung Pharmaceutical Co., Ltd
Contact
Status	Completed
Phase
Start date	June 10, 2020
Completion date	June 24, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor — DETECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms