Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
A Phase II Clinical Study of Lactobacillus Vaginalis Capsules for the Prevention and Treatment of Symptoms of Vulvovaginal Atrophy in Young Breast Cancer Patients Receving Ovarian Function Suppression (OFS) During Chemotherapy
The First Affiliated Hospital with Nanjing Medical University
60 participants
Aug 24, 2023
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria8
- 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.
Interventions
This product is a micro-ecological preparation made from live Lactobacillus and is used for the treatment of vaginosis caused by disorders of the flora.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05974449