Evaluating ethanol effects in breast cancer patients undergoing chemotherapy
Official title: 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
Run by Boryung Pharmaceutical Co., Ltd · NCT06537752 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 1052 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Status | Recruiting |
| Started | July 15, 2024 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT06537752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include breast cancer patients requiring neoadjuvant or adjuvant chemotherapy who are scheduled to receive non-ethanol formulation docetaxel.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.