Status:
RECRUITING
Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
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 fo...
Detailed Description
Breast cancer is the most common malignancy in women, and its incidence is increasing year by year. While systemic combination therapy (e.g., Chemotherapy, endocrine therapy, targeted therapy, etc.) c...
Eligibility Criteria
Inclusion
- Pathologically confirmed invasive breast cancer (regardless of pathology type);
- Female patients 18-40 years of age with unlimited HR, or 41-45 years of age with negative HR;
- Patients expected to receive ≥4 cycles of chemotherapy containing paclitaxel or anthracycline-containing chemotherapeutic agents and ovarian protective drugs;
- Pre-menopausal (including perimenopausal);
- Good compliance, normal comprehension and ability to receive treatment as required;
- ECOG score 0-1;
- Patients volunteered to participate in this study and signed an informed consent form.
Exclusion
- Use of any other vaginal medication in the 3 months prior to the study;
- Use of any anti-infective medication in the 3 months prior to the study;
- Active genital tract infection;
- Previous development of other malignancies;
- Any reason why they are unable to complete the full course of follow-up treatment as prescribed by their doctors;
- 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;
- Severe coagulation disorder, severe systemic disease, or uncontrollable infection;
- 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.
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05974449
Start Date
August 24 2023
End Date
December 31 2025
Last Update
December 12 2024
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China