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

Breast Cancer Clinical Trial

— DETECT  

Official title:

A Multi-center, Prospective, Observational Study to Evaluate Ethanol-induced Symptoms in Patients With Chemotherapy of Docetaxel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545632
• Other study ID #: BR-DTX-OS-401
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: July 2022
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: June 24, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subjects who provide written informed consent to collect and use personal information after an explanation of the objectives and methods of the study

2. Adult males and females aged 19 years and older

3. Chemotherapy with ethanol-containing docetaxel (=50 mg/m2) alone or in combination for a pathologically confirmed cancer

4. ECOG Performance Status (ECOG PS) scores =2

5. Patients who are capable of understanding the questionnaire items and directly answering questions

Exclusion Criteria:

1. History of psychiatric disorder, seizure, or central nervous system disorder

2. Metastasis to the central nervous system (although patients without neurological symptoms are eligible)

3. Active hepatitis

4. Individuals who meet any of the following:

• AST/ALT =2 X upper limit of normal (ULN)

• Total bilirubin =2 X ULN

• Hemoglobin <9.0 g/dL

5. Combination chemotherapy with ethanol-containing anticancer drugs other than docetaxel

6. Alcohol, hypnotic or tranquilizer intake within 24 hours before treatment with docetaxel

7. Pregnant or nursing women or women of childbearing potential

8. 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.

9. Patients who are otherwise considered by the investigator to be ineligible for this study

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri-si

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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
Secondary	Incidence of ethanol-induced symptoms as a whole during and at each time point after treatment	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
Secondary	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