Evaluating ethanol effects in breast cancer patients undergoing chemotherapy
A Multi-center, Prospective, Observational stuDy to Evaluate EThanOl-induced Symptoms and Safety in Breast Cancer Patients witH Neoadjuvant/Adjuvant Chemotherapy Including Non-ethanol Formulation Docetaxel Before and After Surgery
This study is testing how safe ethanol is for breast cancer patients getting chemotherapy and if it causes any symptoms before and after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1052 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06537752 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the symptoms and safety associated with ethanol in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy, specifically those treated with a non-ethanol formulation of docetaxel. Participants will be monitored before and after surgery to evaluate any ethanol-induced symptoms. The study seeks to gather data on the safety profile of ethanol in this patient population, contributing to a better understanding of its effects during chemotherapy.
Who should consider this trial
Good fit: Ideal candidates include breast cancer patients requiring neoadjuvant or adjuvant chemotherapy who are scheduled to receive non-ethanol formulation docetaxel.
Not a fit: Patients with other primary cancers, secondary breast cancers, or those with early-stage or advanced-stage breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of ethanol consumption for breast cancer patients undergoing chemotherapy, potentially improving patient care.
How similar studies have performed: While there may be limited data on ethanol's effects in this specific context, similar studies evaluating safety profiles in chemotherapy have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study. * Those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable. * Those who need neoadjuvant chemotherapy as breast cancer patients * Those who need adjuvant chemotherapy after breast cancer surgery * Those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy * Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. Exclusion Criteria: * Those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers. * Those are diagnosed with secondary breast cancers. * Those with Stage 0/1 (Tis, N0, M0) or Stage IV (any T, Any N, M1) breast cancers.
Where this trial is running
Seoul and 1 other locations
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
- Uijeongbu Eulji Medical Center, Eulji University — Uijeongbu-si, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Shin-young Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.