Clinical trial NCT04545632: Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor
Official title: A Multi-center, Prospective, Observational Study to Evaluate Ethanol-induced Symptoms in Patients With Chemotherapy of Docetaxel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
NSCLC
Prostate Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Ovarian Cancer
Keywords: Chemotherapy
Ethanol-containing docetaxel
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 458
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving chemotherapy with ethanol-containing docetaxel

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ethanol-induced symptoms as a whole
timeFrame: Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment)
Secondary outcomes:
measure: Incidence of each ethanol-induced symptom
timeFrame: Baseline visit - before, during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
measure: Incidence of ethanol-induced symptoms as a whole during and at each time point after treatment
timeFrame: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
measure: Incidence of each ethanol-induced symptom during and at each time point after treatment
timeFrame: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Myung Sook Hong
role: STUDY_DIRECTOR
References: