NCT05974449 Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
| NCT ID | NCT05974449 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-08-24 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Jue Wang, MD
STUDY DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05974449 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05974449 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05974449 currently recruiting?
Yes, NCT05974449 is actively recruiting participants. Contact the research team at 15705227155@163.com for enrollment information.
Where is the NCT05974449 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05974449 clinical trial?
NCT05974449 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Jue Wang, MD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 60 participants.
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