Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients

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 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.

Eligibility

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.

Conditions3

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