Breast CancerDETECTNCT04545632
Docetaxel Ethanol-induced Symptoms; The Incidence and Risk Forecating Factor
An observational study of Breast Cancer and NSCLC, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer, NSCLC, Prostate Cancer
- How many people
- 458 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jun 2020to 24 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving chemotherapy with ethanol-containing docetaxel
Who may be able to join
- Subjects who provide written informed consent to collect and use personal information after an explanation of the objectives and methods of the study
- Adult males and females aged 19 years and older
- Chemotherapy with ethanol-containing docetaxel (≥50 mg/m2) alone or in combination for a pathologically confirmed cancer
- ECOG Performance Status (ECOG PS) scores ≤2
- Patients who are capable of understanding the questionnaire items and directly answering questions
Who cannot join
- History of psychiatric disorder, seizure, or central nervous system disorder
- Metastasis to the central nervous system (although patients without neurological symptoms are eligible)
- Active hepatitis
- Individuals who meet any of the following:
- AST/ALT ≥2 X upper limit of normal (ULN)
- Total bilirubin ≥2 X ULN
Show all 12Show fewer
- Hemoglobin <9.0 g/dL
- Combination chemotherapy with ethanol-containing anticancer drugs other than docetaxel
- Alcohol, hypnotic or tranquilizer intake within 24 hours before treatment with docetaxel
- Pregnant or nursing women or women of childbearing potential
- 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.
- Patients who are otherwise considered by the investigator to be ineligible for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Observational Study to Evaluate Ethanol-induced Symptoms in Patients With Chemotherapy of Docetaxel
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).
Read the 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
- Keywords
- Chemotherapy, Ethanol-containing docetaxel
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Head and Neck Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients receiving chemotherapy with ethanol-containing docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ethanol-induced symptoms as a whole
An increase from baseline in the number of ethanol-induced symptoms during or after treatment
Measured: Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment)
Secondary outcomes (3)
Incidence of each ethanol-induced symptom
Any increase from baseline in the number of each ethanol-induced symptom during or after treatment
Measured: Baseline visit - before, during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
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
Measured: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
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
Measured: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start10 Jun 2020
- Primary completion26 Feb 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Sook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545632
- Sponsor's protocol ID
- BR-DTX-OS-401
- Acronym
- DETECT
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Evaluate Ethanol-induced Symptoms in Patients With Chemotherapy of Docetaxel
- ClinicalTrials.gov ID
- NCT04545632
- Acronym / sponsor ID
- DETECT / BR-DTX-OS-401
- Conditions
- Breast Cancer, NSCLC, Prostate Cancer, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer
- Keywords
- Chemotherapy, Ethanol-containing docetaxel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients receiving chemotherapy with ethanol-containing docetaxel |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chemotherapy with ethanol-containing docetaxel
Key inclusion criteria (5 listed)
- Subjects who provide written informed consent to collect and use personal information after an explanation of the objectives and methods of the study
- Adult males and females aged 19 years and older
- Chemotherapy with ethanol-containing docetaxel (≥50 mg/m2) alone or in combination for a pathologically confirmed cancer
- ECOG Performance Status (ECOG PS) scores ≤2
- Patients who are capable of understanding the questionnaire items and directly answering questions
Key exclusion criteria (12 listed)
- History of psychiatric disorder, seizure, or central nervous system disorder
- Metastasis to the central nervous system (although patients without neurological symptoms are eligible)
- Active hepatitis
- Individuals who meet any of the following:
- Combination chemotherapy with ethanol-containing anticancer drugs other than docetaxel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ethanol-induced symptoms as a whole
Time frame: Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment)
An increase from baseline in the number of ethanol-induced symptoms during or after treatment
3 secondary outcomes
Incidence of each ethanol-induced symptom
Time frame: Baseline visit - before, during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
Incidence of ethanol-induced symptoms as a whole during and at each time point after treatment
Time frame: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
Incidence of each ethanol-induced symptom during and at each time point after treatment
Time frame: Baseline visit - during, and within 30 minutes after treatment, Follow-up visit - 24 hours after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Sook Hong study director
Boryung Pharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and NSCLC, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ethanol-induced symptoms as a whole (time frame: Time Frame : From the time of treatment started until the end of follow-up(24hours after the treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.