Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal Lactobacillus capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- C1, C2 dosing group
- description
- C1 and C2 dosing groups: The drug is administered on the day of the C1 and C2 chemotherapy cycles for 10 days, washing the vulva and placing the drug deep into the vagina, once a night, 1 capsules each time.
- interventionNames
- Drug: Vaginal Lactobacillus capsules
- type
- EXPERIMENTAL
- label
- C3, C4 dosing group
- description
- C3 and C4 dosing groups: The drug is given on the day of the C3 and C4 chemotherapy cycles and is administered for 10 days. The drug is placed deep into the vagina after washing the vulva, once a night, 1 capsules each time.
- interventionNames
- Drug: Vaginal Lactobacillus capsules
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available