💬In plain words
What the trial is, and whether it could suit you
This study is a prospective, randomized controlled, phase II clinical study with a planned enrolment of 60 patients. The study focuses on the efficacy and safety of Lactobacillus vaginalis capsules for the prevention and/or treatment of vulvovaginal symptoms in young breast cancer patients receiving ovarian protection during chemotherapy, in order to improve compliance and quality of life in breast cancer patients.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Pathologically confirmed invasive breast cancer (regardless of pathology type);
2. Female patients 18-40 years of age with unlimited HR, or 41-45 years of age with negative HR;
3. Patients expected to receive ≥4 cycles of chemotherapy containing paclitaxel or anthracycline-containing chemotherapeutic agents and ovarian protective drugs;
4. Pre-menopausal (including perimenopausal);
5. Good compliance, normal comprehension and ability to receive treatment as required;
6. ECOG score 0-1;
7. Patients volunteered to participate in this study and signed an informed consent form.
Exclusion Criteria:
1. Use of any other vaginal medication in the 3 months prior to the study;
2. Use of any anti-infective medication in the 3 months prior to the study;
3. Active genital tract infection;
4. Previous development of other malignancies;
5. Any reason why they are unable to complete the full course of follow-up treatment as prescribed by their doctors;
6. AST and ALT ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; LVEF \< 50% on cardiac ultrasound;
7. Severe coagulation disorder, severe systemic disease, or uncontrollable infection;
8. Persons without personal freedom and independent civil capacity; the presence of mental disorders, addictions, etc., which in the judgment of the investigator do not qualify for enrolment.
💊
What it tests
- Vaginal Lactobacillus capsules
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.