4545632
Last Update Posted: 2022-07-27
Recruiting has ended
All Genders accepted | 19 Years + |
458 Estimated Participants | No Expanded Access |
Observational Study | Does not accept healthy volunteers |
Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor
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
Eligibility
Relevant conditions:
Breast Cancer
NSCLC
Prostate Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Ovarian Cancer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov